Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426381
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-07
Brief Title:
The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety Vital Signs and Comfort Level
Sponsor:
Dilek GÜRÇAYIR
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety Vital Signs and Comfort Level Experimental Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effect of therapeutic touch on patients anxiety vital signs and comfort levels during knee replacement surgery performed under local anesthesia
The study will be completed with a total of 128 participants including 64 experimental and 64 control participants
As a randomization method the simple randomization method will be used to ensure an equal number of samples in two groups and patients will be assigned to the experimental and control groups In the research patients will be given verbal information about the research and written informed consent will be obtained from the patients who accept it
In the study therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs anxiety level and comfort was evaluated
The study will be completed with a total of 128 participants including 64 experimental and 64 control participants
As a randomization method the simple randomization method will be used to ensure an equal number of samples in two groups and patients will be assigned to the experimental and control groups In the research patients will be given verbal information about the research and written informed consent will be obtained from the patients who accept it
In the study therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs anxiety level and comfort was evaluated
Detailed Description:
Knee replacement surgeries are a common treatment method for patients with problems such as pain and limitation of movement resulting from knee joint disorders This type of surgery is usually performed under general anesthesia allowing patients to lose consciousness during surgery However general anesthesia may have some risks and complications For this reason local anesthesia has become increasingly popular
Local anesthesia is a method of anesthesia used to numb the surgical area In this method anesthesia is injected directly into the surgical area and the patient is awake and conscious throughout the surgery Local anesthesia may have fewer side effects and complications compared to general anesthesia However the effects of emotional factors such as stress anxiety and discomfort experienced by patients during surgeries performed under local anesthesia are still poorly understood
The human body is surrounded by an aura and open energy fields It is reported that when these energy fields are balanced the individual is healthy and when they are irregular the individual experiences health problems Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier In this way the person regains his health or can be helped to regain his health Nursing theorist Martha Rogers supports this statement Rogers defined human beings as an open system with a complex and interactive energy field covering the entire universe It is assumed that the energy surrounding humans is in wave form and that changes in the human body are controlled by these energy fluctuations If the person has health problems this manifests itself in the form of energy blockages or rhythm disorders By correcting these energy rhythm disorders discovered by the nurse with the therapeutic touch method the persons health problem can be treated In recent years there has been increasing evidence that alternative approaches such as therapeutic touch have positive effects on surgical outcomes Therapeutic touch is a method that aims to provide relaxation calming and healing through physical contact This method can reduce patients stress levels relieve pain and increase their overall comfort level However there are limited studies on the effect of therapeutic touch on vital signs during knee replacement surgery performed under local anesthesia
Surgeries are widely used as a method of treating various health problems that require medical treatment Knee prosthesis surgeries are one of the frequently used surgical interventions in the treatment of painful and limiting diseases of the knee joint Although such surgeries have the potential to significantly improve individuals mobility and quality of life the stress anxiety and physical discomfort that may occur during and after the surgery can be a significant source of concern for patients
Anxiety is a common psychological reaction before and after surgical interventions and is an important factor affecting the surgical process Patients may experience increased levels of anxiety when faced with uncertainty about the results of surgery possible complications and the recovery process The importance of this situation is of great importance in terms of the success of the surgery and the patients ability to better manage the postoperative period
Anxiety negatively affects the patients comfort level after surgery and can prolong the recovery process Lack of comfort can lead to increased physical and emotional stress caused by surgery It is important to note that because therapeutic touch has the potential to increase patients relaxation stress reduction and overall comfort level research has also been conducted in this area However there is no definitive information about the effect of therapeutic touch on the comfort level during knee replacement surgery performed under local anesthesia
The aim of this study is to investigate the effect of therapeutic touch on patients vital signs anxiety and comfort level during knee replacement surgery performed under local anesthesia This study aims to offer an alternative approach to improve patients quality of life by continuing to improve the results of surgeries performed under local anesthesia This study aims to fill the gap in this field by investigating the effect of therapeutic touch on vital signs anxiety and comfort level during knee replacement surgery performed under local anesthesia The findings may guide clinical practice in providing an alternative approach to improve surgical outcomes and reduce discomfort experienced by patients It may also provide basic information to evaluate the feasibility of therapeutic touch in other surgical procedures under local anesthesia
This study was conducted as an experimental randomized controlled study This method was preferred because it allows the situations and attitudes of the individuals in the group selected as a sample regarding a phenomenon or event and to describe the phenomena and events in their own conditions and as they are In addition in randomized controlled studies the factors that cause events and situations and the degree of influence of these factors can be determined In the study therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs anxiety level and comfort was evaluated The hypotheses created in the research are listed below The research was conducted in the orthopedics and traumatology room in the operating room department of Atatürk University Training and Research Hospital between September 2023 and June 2024
The population of the research consists of patients who had knee replacement surgery between September 2023 and February 2024 The sample of the research consists of patients who meet the inclusion criteria between the specified dates Cohens standard effect sizes were used as reference in the power analysis In this case in this study for the t test in independent groups where the effect of therapeutic touch during knee prosthesis surgery will be compared on vital signs anxiety and comfort levels if the study is conducted with a total of 128 participants in two groups with 64 participants in each group 80 confidence interval is 95 at a significance level of 005 It has been determined that power can be achieved As a randomization method the simple randomization method was used to ensure an equal number of samples in two groups and the patients were assigned to the experimental and control groups In the study patients were given verbal information about the research and written informed consent was obtained from the patients who agreed
Four different forms were used to collect data in the study The Anxiety and Comfort Scale which was determined as the data collection tool in the study was chosen by the researcher as it was deemed suitable for the purpose Analyzes were carried out with the data obtained to test the validity and reliability of the selected scale In order to ensure that the data collection tools do not pose an ethical problem people with expertise on the subject were consulted and it was ensured that they would not cause any problems However the scale questions were reviewed in detail by the researcher and the consultant and since an application was actually made in the form of a Likert scale leaving the selection decision entirely to the participants refutes the idea that it is a manipulation The forms used to collect data are listed below
1 Patient Introduction Form
2 Vital Signs Record Form
3 Spielberg State-Trait Anxiety Scale
4 Perianesthesia Comfort Scale PCS In order to conduct the research firstly approval was obtained from the Atatürk University Faculty of Medicine Ethics Committee and institutional permission was obtained from the hospital where the research was conducted Verbal consent was obtained from the patients before data collection and data collection forms were collected by the researcher in the orthopedics and traumatology room in the operating room department by face-to-face interview Patients who accepted the study and met the criteria were included in the experimentalcontrol group by randomization
In patients included in the experimental group On the day of surgery patients who met the research criteria were met the purpose of the study was explained and their written consent was obtained The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique When the patient was taken to the operating table the Vital Signs Record Form was filled out Then therapeutic touch was applied for 15-20 minutes during the surgery After the procedure was completed the Vital Signs Record Form Spielberg State Anxiety Scale and Perianesthesia Comfort Scale PCS were administered
In patients included in the control group On the day of surgery patients who met the research criteria were met the purpose of the study was explained and their written consent was obtained The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique When the patient was taken to the operating table the Vital Signs Record Form was filled out After the procedure is completed the Vital Signs Record Form Spielberg State Anxiety Scale and Perianesthesia Comfort Scale PCS will be administered No procedure was applied to the control group
Local anesthesia is a method of anesthesia used to numb the surgical area In this method anesthesia is injected directly into the surgical area and the patient is awake and conscious throughout the surgery Local anesthesia may have fewer side effects and complications compared to general anesthesia However the effects of emotional factors such as stress anxiety and discomfort experienced by patients during surgeries performed under local anesthesia are still poorly understood
The human body is surrounded by an aura and open energy fields It is reported that when these energy fields are balanced the individual is healthy and when they are irregular the individual experiences health problems Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier In this way the person regains his health or can be helped to regain his health Nursing theorist Martha Rogers supports this statement Rogers defined human beings as an open system with a complex and interactive energy field covering the entire universe It is assumed that the energy surrounding humans is in wave form and that changes in the human body are controlled by these energy fluctuations If the person has health problems this manifests itself in the form of energy blockages or rhythm disorders By correcting these energy rhythm disorders discovered by the nurse with the therapeutic touch method the persons health problem can be treated In recent years there has been increasing evidence that alternative approaches such as therapeutic touch have positive effects on surgical outcomes Therapeutic touch is a method that aims to provide relaxation calming and healing through physical contact This method can reduce patients stress levels relieve pain and increase their overall comfort level However there are limited studies on the effect of therapeutic touch on vital signs during knee replacement surgery performed under local anesthesia
Surgeries are widely used as a method of treating various health problems that require medical treatment Knee prosthesis surgeries are one of the frequently used surgical interventions in the treatment of painful and limiting diseases of the knee joint Although such surgeries have the potential to significantly improve individuals mobility and quality of life the stress anxiety and physical discomfort that may occur during and after the surgery can be a significant source of concern for patients
Anxiety is a common psychological reaction before and after surgical interventions and is an important factor affecting the surgical process Patients may experience increased levels of anxiety when faced with uncertainty about the results of surgery possible complications and the recovery process The importance of this situation is of great importance in terms of the success of the surgery and the patients ability to better manage the postoperative period
Anxiety negatively affects the patients comfort level after surgery and can prolong the recovery process Lack of comfort can lead to increased physical and emotional stress caused by surgery It is important to note that because therapeutic touch has the potential to increase patients relaxation stress reduction and overall comfort level research has also been conducted in this area However there is no definitive information about the effect of therapeutic touch on the comfort level during knee replacement surgery performed under local anesthesia
The aim of this study is to investigate the effect of therapeutic touch on patients vital signs anxiety and comfort level during knee replacement surgery performed under local anesthesia This study aims to offer an alternative approach to improve patients quality of life by continuing to improve the results of surgeries performed under local anesthesia This study aims to fill the gap in this field by investigating the effect of therapeutic touch on vital signs anxiety and comfort level during knee replacement surgery performed under local anesthesia The findings may guide clinical practice in providing an alternative approach to improve surgical outcomes and reduce discomfort experienced by patients It may also provide basic information to evaluate the feasibility of therapeutic touch in other surgical procedures under local anesthesia
This study was conducted as an experimental randomized controlled study This method was preferred because it allows the situations and attitudes of the individuals in the group selected as a sample regarding a phenomenon or event and to describe the phenomena and events in their own conditions and as they are In addition in randomized controlled studies the factors that cause events and situations and the degree of influence of these factors can be determined In the study therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs anxiety level and comfort was evaluated The hypotheses created in the research are listed below The research was conducted in the orthopedics and traumatology room in the operating room department of Atatürk University Training and Research Hospital between September 2023 and June 2024
The population of the research consists of patients who had knee replacement surgery between September 2023 and February 2024 The sample of the research consists of patients who meet the inclusion criteria between the specified dates Cohens standard effect sizes were used as reference in the power analysis In this case in this study for the t test in independent groups where the effect of therapeutic touch during knee prosthesis surgery will be compared on vital signs anxiety and comfort levels if the study is conducted with a total of 128 participants in two groups with 64 participants in each group 80 confidence interval is 95 at a significance level of 005 It has been determined that power can be achieved As a randomization method the simple randomization method was used to ensure an equal number of samples in two groups and the patients were assigned to the experimental and control groups In the study patients were given verbal information about the research and written informed consent was obtained from the patients who agreed
Four different forms were used to collect data in the study The Anxiety and Comfort Scale which was determined as the data collection tool in the study was chosen by the researcher as it was deemed suitable for the purpose Analyzes were carried out with the data obtained to test the validity and reliability of the selected scale In order to ensure that the data collection tools do not pose an ethical problem people with expertise on the subject were consulted and it was ensured that they would not cause any problems However the scale questions were reviewed in detail by the researcher and the consultant and since an application was actually made in the form of a Likert scale leaving the selection decision entirely to the participants refutes the idea that it is a manipulation The forms used to collect data are listed below
1 Patient Introduction Form
2 Vital Signs Record Form
3 Spielberg State-Trait Anxiety Scale
4 Perianesthesia Comfort Scale PCS In order to conduct the research firstly approval was obtained from the Atatürk University Faculty of Medicine Ethics Committee and institutional permission was obtained from the hospital where the research was conducted Verbal consent was obtained from the patients before data collection and data collection forms were collected by the researcher in the orthopedics and traumatology room in the operating room department by face-to-face interview Patients who accepted the study and met the criteria were included in the experimentalcontrol group by randomization
In patients included in the experimental group On the day of surgery patients who met the research criteria were met the purpose of the study was explained and their written consent was obtained The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique When the patient was taken to the operating table the Vital Signs Record Form was filled out Then therapeutic touch was applied for 15-20 minutes during the surgery After the procedure was completed the Vital Signs Record Form Spielberg State Anxiety Scale and Perianesthesia Comfort Scale PCS were administered
In patients included in the control group On the day of surgery patients who met the research criteria were met the purpose of the study was explained and their written consent was obtained The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique When the patient was taken to the operating table the Vital Signs Record Form was filled out After the procedure is completed the Vital Signs Record Form Spielberg State Anxiety Scale and Perianesthesia Comfort Scale PCS will be administered No procedure was applied to the control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None