Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608264
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Effects of Stress Ball and Hand Holdig on Pain and Mobility Levels During Continuous Passive Motion In Patients With Total Knee Prosthesis A Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Stress Ball and Hand Holdig on Pain and Mobility Levels During Continuous Passive Motion In Patients With Total Knee Prosthesis A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pain after Total Knee Prosthesis TKA is an important problemWhen pain is not controlled it can negatively affect the patientsampampamp39 mobility levelThis research A randomized controlled experimental design was planned to examine the effects of stress ball and hand holding on pain and mobility levels in patients who underwent Continuous Passive Movement CPM after TOTAL knee prosthesisThe study was planned to be conducted between 15072024 and 15122025 on patients who who had total knee prosthesis surgery at the Aksaray University Training and Research Hospital Orthopedics and Traumatology ClinicSince no study similar to our study design was found in the literature the sample size of the study was calculated as 22 patients in each arm with Cohen effect sizes for VAS 3 arms 2 repeated measurements a medium effect size of 025 effect 95 power and 5 type 1 error levelConsidering that there may be data loss in the study the sample size was increased by 20 and a total of 78 patients 26 in each armAssignment of patients to stress ball hand holding and control arm using block randomization methodDetermining by drawing lots which letters will represent the stress ball hand holding and control arms as A B CThe blocks were planned to be created by a statisticianStress ball intervention to the stress ball arm during continuous passive movement exerciseampampampampamp34Hand holding interventionampampampampamp34 will be made to the hand holding armNo intervention other than standard maintenance will be made to the control armThe implementation of the study will be carried out by the researcher RS and will be blinded to random assignmentOn the 1st and 2nd days after total knee prosthesis exercises are performed for 30 minutes with continuous passive movementConsidering this situation and the literature the pain levels of the patients will be evaluated a total of 4 times on the 1st and 2nd days before the CPM exercise at the 5th minute 15th minute and at the end of the exercise 30th minute Mobility levels will be evaluated at this time as the patient is mobilized within 1-2 hours after exerciseIt was planned to collect the data with the Patient Questionnaire Form Pain Assessment Form Patient Mobility Scale and Observer Mobility ScalePermission to use the scales was obtained via e-mail Ethics committee and institution permissions were obtained to start the studyData will be compared using Pearson chi-square Fisher exact test One-way ANOVA and repeated measures ANOVA Kruskal Wallis testIt was planned to obtain informed consent from the patients before the studyThe study is limited by the inclusion of patients with ASA I and II who underwent total knee prosthesis with a single physician and a single surgical technique at the Aksaray University Training and Research Hospital Orthopedics and Traumatology Clinic regardless of whether they had chronic diseasesThe study results can be used in planning the pain management of patientsIt is thought that complications that may occur due to delayed mobilization and immobility can be prevented in patients whose pain is reduced
Detailed Description:
Type of researchThis study was planned as a randomized controlled experimental design to investigate the effects of stress ball and hand holding on pain and mobility levels during continuous passive movement in patients with total knee prosthesis
Research hypotheses
H0 1 There is no difference in the pain levels of stress ball hand holding and control arms during CPM in patients with total knee arthroplasty
H1 1 There is a difference in the pain levels of stress ball hand holding and control arms during CPM in patients with total knee prosthesis
H0 2 There is no difference in the mobility levels of stress ball hand holding and control arms during CPM in patients with total knee prosthesis
H1 2 There is a difference in the mobility levels of stress ball hand holding and control arms during CPM in patients with total knee prosthesis
Universe of the researchThe universe of the study will consist of patients who underwent total knee prosthesis in the Orthopedics and Traumatology Clinics of Aksaray University Training and Research Hospital
Sample of the study Since no study similar to our study design was found in the literature the sample size of the study was calculated as 66 patients in total 22 in each arm with a medium effect size of 025 in 2 repeated measurements 95 power and 5 type 1 error level with 3 arms for Cohen effect sizes for VAS Considering that there may be data loss in the study the sample size was increased by 20 in order not to decrease the statistical power and a total of 78 patients 26 in each arm Suresh and Chandrashekara 2012
Collection of research data
The Patient Questionnaire Form which was developed by the researcher as a result of literature reviews Dağcı 2023 Khan et al 2021 Ursavaş and Yaradılmış 2021 Özbaş 2020 Yıldırım and Şendir 2019 Mete and Avcı Işık 2020 consists of seven questions to evaluate age gender marital status education employment economic status and weight Part IIt consists of two sections namely information on treatment and care Section II which consists of three questions on the presence of chronic diseases ASA classification and patient examinations
Pain Assessment Form was created to record the pain of patients before and during continuous passive exercise on the first and second day after total knee prosthesis by evaluating it with Visual Analog Scale 4 stages
Patient Mobility Scale Scala was developed by Heye and his colleagues in 2002 and its validity and reliability study was conducted by Ayoğlu in 2011The Patient Mobility Scale determines the level of pain and difficulty that patients will experience during any activity after surgeryAfter the surgical procedure the pain and difficulty levels that patients develop while performing 4 activities such as turning from one side to the other in bed sitting on the edge of the bed standing up on the edge of the bed and walking in the patient room are assessed with a 15 cm visual scale which is verbally expressed by the patientsThe degree of pain and difficulty of the patients is evaluated by measuring the distance between the mark they put on the scale and 0 with a calibrated rulerPatients are asked 2 questions for each activity in the scalePatients answer questions measuring the level and severity of pain perception using a five-point Likert-type scale 1 no pain 2 a little pain 3 moderate pain 4 a lot of pain 5 the worst pain I could imagine and the difficulty levels of the activities using a five-point Likert-type scale 1 It was very easy 2 It was easy 3 It was a little difficult 4 It was difficult 5 It was very difficultThe lowest and highest scores that can be obtained from each item vary between 0-15 and the total scale score varies between 0-120In the scale evaluation an increase in the score indicates that the level of pain and difficulty during the implementation of the four activities increasesA decrease in the score indicates that the level of pain and difficulty in performing the four activities in patients decreases and the difficulty in moving decreases
The Observer Mobility Scale developed by Heye and colleagues in 2002 evaluates objective observations of movement during four activities in which patients perform postoperative activities such as turning from one side to the other in bed sitting at the edge of the bed standing up at the edge of the bed and walking in the patient roomDependencyindependence status is numbered from 1 to 5 A scale score of 1 indicates that the person performs the relevant activity independently without verbal warning or physical assistanceThe number 5 indicates that the patient is unable to perform the relevant activity despite verbal warning or physical assistanceEvaluation of the scale the average score of the scale is obtained by summing the scores for the four activities that make up each item of the scaleScores between 4 and 20 are obtained from the scaleAs a result of the evaluation an increase in the score indicates that the patients have a sufficient level of movement and a decrease in the score indicates that the patients do not have a sufficient level of movement
Research Data CollectionThe research data were planned to be collected from patients who underwent total knee prosthesis in the Orthopedics and Traumatology Clinic between 20092024 and 15122025Postoperative day 0 Continuous passive movement is not applied and the patient is not mobilizedOn postoperative day I patients will be evaluated according to inclusion and exclusion criteria by researcher RSPatients who meet the inclusion criteria will be interviewed face to face to be informed about the research and patients who volunteer to participate in the research will be asked to sign an Informed Consent FormAt this stage it is not known by the researcher RS and the patient which group the patients will be included in The Patient Questionnaire Form will be applied to all patientsAfter this stage the arm to which the patient will be assigned stress ball hand holding and control arm will be notified to the researcher by the consultant SF just before the intervention according to the block randomization list created by the statistics expertJust before the continuous passive exercise application information will be given to the stress ball arm regarding the stress ball application and data collection process and to the hand holding arm regarding the hand holding application and data collection processThe control arm will only be given information about the data collection process and no intervention other than standard care will be made
Stress ball interventionA medium hard round high quality stress ball of the same brand will be given to the patientampampampampamp39s actively used hand 1-2 minutes before starting the continuous passive movement exercise by the researcherThe patient will be asked to squeeze and loosen the stress ball for up to 5 counts during the continuous passive movement exerciseAfter squeezing the stress ball the patient should count to 5 and then release itThe patient will be asked to continue this process until the continuous passive movement exercise is completed
Hand holding intervention It will be done by the person the patient prefersBefore the SPH exercise the person concerned will sit next to the patientamp39s bed and warm their hands to a level that will not disturb the patient1-2 minutes before the continuous passive exercise the patient will hold the patientamp39s hand with one hand without using gloves with moderate pressure without rubbing or squeezing to an uncomfortable levelHand holding intervention will continue until the continuous passive movement exercise is completed
The pain level of the patients during the continuous passive motion procedure will be evaluated with VAS in 4 stages before the CPM exercise at the 5th minute at the 15th minute and at the end of the exercise 30th minute with reference to the studies of Hsu et al 2019 and Özgür and Rızalar 2021The patient will mark the pain intensity on the 100 mm line 4 times on the Pain Assessment Form The mobility level of the patients will be evaluated with the 34Patient Mobility Scale34 and 34Observer Mobility Scale34 during the mobilization process after continuous passive motion exercise on the 1st and 2nd days after total knee prosthesis in line with the literature review Sütçü 2022 Danç 2019
All patients are mobilized by the orthosis-prosthesis technician within 1-2 hours after continuous passive movement exercisesThe Patient Mobility Scale and the Observer Mobility Scale will be applied during Turning from One Side to the Other in Bed Sitting at the Edge of the Bed Standing at the Edge of the Bed and Walking in the Patient RoomFor the Patient Mobility Scale the patient is expected to mark on a 150 mm line the level of pain and difficulty heshe experiences after performing each of these four stepsThe 4 activities that constitute the subgroup of patient mobility will be observed simultaneously by the researcher RS and the orthosis-prosthesis technicianThe Observer Mobility Scale will be evaluated simultaneously by two observers at these stages and filled in according to common opinionWhile filling out the Visual Analog Scale Patient Mobility Scale and Observer Mobility ScaleThe markings made by the patient will be measured and recorded with the same ruler calibrated by the researcher after the procedureMedical treatments for pain were standardized with the physician taking into account the life of the drug paracetamol usedApplication of treatment other than this standardized treatment before Continuous Passive Movement and mobilization has been added to the exclusion criteria However Patients who defined 4 or more pain levels after the procedure would be unethical to withhold analgesic treatment and Since it will not affect the Visual Analog Scale Patient Mobility Scale and Observer Mobility Scale values used in the study additional analgesic treatment can be applied
Variables of the Study Independent VariablesHand holding application stress ball application Dependent VariablesPain levels Patient Mobility Levels Ethical Aspects of the ResearchEthics Committee permission was obtained for the implementation of the researchInstitutional permission was received from Aksaray Provincial Health Directorate to conduct the implementation phase of the research at Aksaray University Training and Research HospitalPermission was obtained from Tuluha AYOĞLU via e-mail for the use of the Patient Mobility Scale and Observer Mobility ScalePatients who will be included in the research will be informed that their research data will be used only for academic purposesPreliminary information will be provided that all initiatives to be implemented are carried out in line with universal ethical principlesInformed Consent will be obtained verbally and in writing
Limitations of the StudyThe treatment and care process of the patients is shaped according to the routine practices of this hospitalPatients who underwent total knee prosthesis at the Orthopedics and Traumatology Clinic of Aksaray University Training and Research Hospital were included in the studyLimited to a single physician and a single surgical technique paramedial arthrotomy Since the possible chronic diseases of the patients cannot be predicted whether they have chronic diseases or not is ignoredTaking the ASA assessment into account ASA I and II patients were included in the study and those with III IV and V were excluded thus attempting to ensure similarity in the health status of the patients
Statistical Evaluation of Data Data will be evaluated in the statistical package program IBM SPSS Statistics 260 IBM Corp Armonk New York USA Descriptive statistics will be given as number of units n percentage meanstandard deviation median smallest value largest value and percentile valuesThe normal distribution of data belonging to numerical variables will be evaluated with the Shapiro Wilk normality testIf the data show a normal distribution Visual Anolaog Scale comparisons according to the measurement times of the arms will be made with Two-Way Analysis of Variance in Repeated Measurements from general linear modelsBonferroni correction will be applied to all pairwise comparisonsObserver and patient mobility scale scores obtained after 60 minutes of Continuous passive arm movement exercise will be compared using One-Way Analysis of Variance If the Ho hypothesis is rejected in one-way analysis of variance the Duncan test will be used as a multiple comparison test If the data do not show a normal distribution comparisons between arms are made using Kruskal-Wallis Analysis Intra-arm comparisons will be made with Wilcoxon analysis If a difference is found in the Kruskal-Wallis Analysis the Dunn-Bonferroni test will be used as a multiple comparison testChi square analysis Pearson chi square or Fisher exact test will be used to compare the arms with categorical variables pampampampampampampampampamplt005 will be considered statistically significant
Research hypotheses
H0 1 There is no difference in the pain levels of stress ball hand holding and control arms during CPM in patients with total knee arthroplasty
H1 1 There is a difference in the pain levels of stress ball hand holding and control arms during CPM in patients with total knee prosthesis
H0 2 There is no difference in the mobility levels of stress ball hand holding and control arms during CPM in patients with total knee prosthesis
H1 2 There is a difference in the mobility levels of stress ball hand holding and control arms during CPM in patients with total knee prosthesis
Universe of the researchThe universe of the study will consist of patients who underwent total knee prosthesis in the Orthopedics and Traumatology Clinics of Aksaray University Training and Research Hospital
Sample of the study Since no study similar to our study design was found in the literature the sample size of the study was calculated as 66 patients in total 22 in each arm with a medium effect size of 025 in 2 repeated measurements 95 power and 5 type 1 error level with 3 arms for Cohen effect sizes for VAS Considering that there may be data loss in the study the sample size was increased by 20 in order not to decrease the statistical power and a total of 78 patients 26 in each arm Suresh and Chandrashekara 2012
Collection of research data
The Patient Questionnaire Form which was developed by the researcher as a result of literature reviews Dağcı 2023 Khan et al 2021 Ursavaş and Yaradılmış 2021 Özbaş 2020 Yıldırım and Şendir 2019 Mete and Avcı Işık 2020 consists of seven questions to evaluate age gender marital status education employment economic status and weight Part IIt consists of two sections namely information on treatment and care Section II which consists of three questions on the presence of chronic diseases ASA classification and patient examinations
Pain Assessment Form was created to record the pain of patients before and during continuous passive exercise on the first and second day after total knee prosthesis by evaluating it with Visual Analog Scale 4 stages
Patient Mobility Scale Scala was developed by Heye and his colleagues in 2002 and its validity and reliability study was conducted by Ayoğlu in 2011The Patient Mobility Scale determines the level of pain and difficulty that patients will experience during any activity after surgeryAfter the surgical procedure the pain and difficulty levels that patients develop while performing 4 activities such as turning from one side to the other in bed sitting on the edge of the bed standing up on the edge of the bed and walking in the patient room are assessed with a 15 cm visual scale which is verbally expressed by the patientsThe degree of pain and difficulty of the patients is evaluated by measuring the distance between the mark they put on the scale and 0 with a calibrated rulerPatients are asked 2 questions for each activity in the scalePatients answer questions measuring the level and severity of pain perception using a five-point Likert-type scale 1 no pain 2 a little pain 3 moderate pain 4 a lot of pain 5 the worst pain I could imagine and the difficulty levels of the activities using a five-point Likert-type scale 1 It was very easy 2 It was easy 3 It was a little difficult 4 It was difficult 5 It was very difficultThe lowest and highest scores that can be obtained from each item vary between 0-15 and the total scale score varies between 0-120In the scale evaluation an increase in the score indicates that the level of pain and difficulty during the implementation of the four activities increasesA decrease in the score indicates that the level of pain and difficulty in performing the four activities in patients decreases and the difficulty in moving decreases
The Observer Mobility Scale developed by Heye and colleagues in 2002 evaluates objective observations of movement during four activities in which patients perform postoperative activities such as turning from one side to the other in bed sitting at the edge of the bed standing up at the edge of the bed and walking in the patient roomDependencyindependence status is numbered from 1 to 5 A scale score of 1 indicates that the person performs the relevant activity independently without verbal warning or physical assistanceThe number 5 indicates that the patient is unable to perform the relevant activity despite verbal warning or physical assistanceEvaluation of the scale the average score of the scale is obtained by summing the scores for the four activities that make up each item of the scaleScores between 4 and 20 are obtained from the scaleAs a result of the evaluation an increase in the score indicates that the patients have a sufficient level of movement and a decrease in the score indicates that the patients do not have a sufficient level of movement
Research Data CollectionThe research data were planned to be collected from patients who underwent total knee prosthesis in the Orthopedics and Traumatology Clinic between 20092024 and 15122025Postoperative day 0 Continuous passive movement is not applied and the patient is not mobilizedOn postoperative day I patients will be evaluated according to inclusion and exclusion criteria by researcher RSPatients who meet the inclusion criteria will be interviewed face to face to be informed about the research and patients who volunteer to participate in the research will be asked to sign an Informed Consent FormAt this stage it is not known by the researcher RS and the patient which group the patients will be included in The Patient Questionnaire Form will be applied to all patientsAfter this stage the arm to which the patient will be assigned stress ball hand holding and control arm will be notified to the researcher by the consultant SF just before the intervention according to the block randomization list created by the statistics expertJust before the continuous passive exercise application information will be given to the stress ball arm regarding the stress ball application and data collection process and to the hand holding arm regarding the hand holding application and data collection processThe control arm will only be given information about the data collection process and no intervention other than standard care will be made
Stress ball interventionA medium hard round high quality stress ball of the same brand will be given to the patientampampampampamp39s actively used hand 1-2 minutes before starting the continuous passive movement exercise by the researcherThe patient will be asked to squeeze and loosen the stress ball for up to 5 counts during the continuous passive movement exerciseAfter squeezing the stress ball the patient should count to 5 and then release itThe patient will be asked to continue this process until the continuous passive movement exercise is completed
Hand holding intervention It will be done by the person the patient prefersBefore the SPH exercise the person concerned will sit next to the patientamp39s bed and warm their hands to a level that will not disturb the patient1-2 minutes before the continuous passive exercise the patient will hold the patientamp39s hand with one hand without using gloves with moderate pressure without rubbing or squeezing to an uncomfortable levelHand holding intervention will continue until the continuous passive movement exercise is completed
The pain level of the patients during the continuous passive motion procedure will be evaluated with VAS in 4 stages before the CPM exercise at the 5th minute at the 15th minute and at the end of the exercise 30th minute with reference to the studies of Hsu et al 2019 and Özgür and Rızalar 2021The patient will mark the pain intensity on the 100 mm line 4 times on the Pain Assessment Form The mobility level of the patients will be evaluated with the 34Patient Mobility Scale34 and 34Observer Mobility Scale34 during the mobilization process after continuous passive motion exercise on the 1st and 2nd days after total knee prosthesis in line with the literature review Sütçü 2022 Danç 2019
All patients are mobilized by the orthosis-prosthesis technician within 1-2 hours after continuous passive movement exercisesThe Patient Mobility Scale and the Observer Mobility Scale will be applied during Turning from One Side to the Other in Bed Sitting at the Edge of the Bed Standing at the Edge of the Bed and Walking in the Patient RoomFor the Patient Mobility Scale the patient is expected to mark on a 150 mm line the level of pain and difficulty heshe experiences after performing each of these four stepsThe 4 activities that constitute the subgroup of patient mobility will be observed simultaneously by the researcher RS and the orthosis-prosthesis technicianThe Observer Mobility Scale will be evaluated simultaneously by two observers at these stages and filled in according to common opinionWhile filling out the Visual Analog Scale Patient Mobility Scale and Observer Mobility ScaleThe markings made by the patient will be measured and recorded with the same ruler calibrated by the researcher after the procedureMedical treatments for pain were standardized with the physician taking into account the life of the drug paracetamol usedApplication of treatment other than this standardized treatment before Continuous Passive Movement and mobilization has been added to the exclusion criteria However Patients who defined 4 or more pain levels after the procedure would be unethical to withhold analgesic treatment and Since it will not affect the Visual Analog Scale Patient Mobility Scale and Observer Mobility Scale values used in the study additional analgesic treatment can be applied
Variables of the Study Independent VariablesHand holding application stress ball application Dependent VariablesPain levels Patient Mobility Levels Ethical Aspects of the ResearchEthics Committee permission was obtained for the implementation of the researchInstitutional permission was received from Aksaray Provincial Health Directorate to conduct the implementation phase of the research at Aksaray University Training and Research HospitalPermission was obtained from Tuluha AYOĞLU via e-mail for the use of the Patient Mobility Scale and Observer Mobility ScalePatients who will be included in the research will be informed that their research data will be used only for academic purposesPreliminary information will be provided that all initiatives to be implemented are carried out in line with universal ethical principlesInformed Consent will be obtained verbally and in writing
Limitations of the StudyThe treatment and care process of the patients is shaped according to the routine practices of this hospitalPatients who underwent total knee prosthesis at the Orthopedics and Traumatology Clinic of Aksaray University Training and Research Hospital were included in the studyLimited to a single physician and a single surgical technique paramedial arthrotomy Since the possible chronic diseases of the patients cannot be predicted whether they have chronic diseases or not is ignoredTaking the ASA assessment into account ASA I and II patients were included in the study and those with III IV and V were excluded thus attempting to ensure similarity in the health status of the patients
Statistical Evaluation of Data Data will be evaluated in the statistical package program IBM SPSS Statistics 260 IBM Corp Armonk New York USA Descriptive statistics will be given as number of units n percentage meanstandard deviation median smallest value largest value and percentile valuesThe normal distribution of data belonging to numerical variables will be evaluated with the Shapiro Wilk normality testIf the data show a normal distribution Visual Anolaog Scale comparisons according to the measurement times of the arms will be made with Two-Way Analysis of Variance in Repeated Measurements from general linear modelsBonferroni correction will be applied to all pairwise comparisonsObserver and patient mobility scale scores obtained after 60 minutes of Continuous passive arm movement exercise will be compared using One-Way Analysis of Variance If the Ho hypothesis is rejected in one-way analysis of variance the Duncan test will be used as a multiple comparison test If the data do not show a normal distribution comparisons between arms are made using Kruskal-Wallis Analysis Intra-arm comparisons will be made with Wilcoxon analysis If a difference is found in the Kruskal-Wallis Analysis the Dunn-Bonferroni test will be used as a multiple comparison testChi square analysis Pearson chi square or Fisher exact test will be used to compare the arms with categorical variables pampampampampampampampampamplt005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None