Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484309
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
Nonpharmacological Method for Relief During Episiotomy Repair
Sponsor:
Kocaeli University
Organization:
Kocaeli University
Study Overview
Official Title:
The Effect of Reflexology on Perceived Perineal Pain During Episiotomy Repair
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 study was planned as a randomized controlled trial to evaluate the effect of reflexology on perceived perineal pain during episiotomy repair The research will be carried out with participants who gave birth vaginally at Darıca Farabi Training and Research Hospital between July and December 2024 The research will be carried out with two groups reflexology and control groups Considering the sample size in the R pwrss Statistical Power and Sample Size Calculation Tools program a type 1 alpha error of 005 and a power of 080 it was calculated that the study group should be at least 32 in the reflexology group and 32 in the control group Considering the confounding variables it was planned to recruit 25 more participants for each group and therefore it was decided to recruit 40 participants per group The participants included in the study will be divided into two groups by determining which group they will be included in from the website called Random List a random number generation program Thus each participants number and group number will be determined and recorded Research data will be collected using the Participant Information Form VAS Visual Analog Scale and McGill Ağrı survey which were created by the researcher within the framework of the literature on the subject The data of the research will be evaluated using SPSS IBM 290 program In evaluating the data Descriptive statistics and comparative statistical analyzes will be used Statistical significance level will be accepted as p005
Detailed Description:
Aim To examine the effect of reflexology on perceived perineal pain during episiotomy repair
Hypothesiss
H0 There is no difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair
H1 There is a difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair
Type of Research This study was designed as a randomized controlled experimental study
In order to determine the sample size in the study it was calculated according to the research conducted by Sharifi et al 2022 Considering the sample size in the R pwrss Statistical Power and Sample Size Calculation Tools program a type 1 alpha error of 005 and a power of 080 it was calculated that the study group should be at least 32 in the reflexology group and 32 in the control group Considering the confounding variables it was planned to recruit 25 more participants for each group and therefore it was decided to recruit 40 participants per group 80 participants in total
The participants included in the study will be divided into two groups by determining which group they will be included in from the website called Random List a random number generation program Thus each participants number and group number will be determined and recorded
Research data will be collected using the Participant Information Form VAS Visual Analog Scale and McGill Pain questionnaire to assess pain during episiotomy repair
Participant Information Form It was prepared by the researcher within the framework of the literature The form consists of a total of 14 questions that question womens socio-demographic and obstetrics-related information
VAS for Evaluation Pain during Episiotomy Repair The participant marks his or her own pain on a 10 cm ruler which is marked as no pain at one end and the most severe pain at the other end The participant is told that there are two endpoints and to mark any place between these points that matches the severity of the pain The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement The VAS is more sensitive than the simple descriptive scale
McGill Short Form for Assessment of Pain Following Episiotomy Repair The McGill Pain Questionnaire was developed by Melzack and Torgerson and is used to evaluate pain multidimensionally There are 15 criteria by which pain is evaluated 11 of these criteria are to evaluate the emotional dimension of pain and 4 are to evaluate the perceptual dimension of pain Assessment of pain was rated on an intensity scale from 0 to 3 0 none 1 mild 2 moderate 3 severe In the first part of the scale a total of three pain scores are obtained sensory pain score perceptual pain score and total pain score Sensory pain score ranges from 0-33 perceptual pain score ranges from 0-12 and total pain score ranges from 0-45 An increase in the score indicates that the pain also increases Second Part In this part there are five word groups ranging from mild pain to unbearable pain to determine the severity of the patients pain Third Part In the third part of MAS-CF the patients current pain intensity was evaluated using a visual comparison scale
Application of Research After obtaining the necessary ethics committee and institutional permissions to conduct the research the institution will be visited and participants who gave birth normally with episiotomy and meet the inclusion criteria for the study will be interviewed Data will be collected by the researcher in the hospital delivery room Women will be informed about the research and the purpose of the research will be explained Those who agree to participate in the research will be asked to read and sign the Informed Consent Form Participants who meet the criteria will be divided into reflexology and control groups The website called httpswwwrandomlistscom a random number generation program will be used to determine the selection process Thus each participants number and group number will be determined and recorded Episiotomy repairs will be performed by the same midwife We were going to do another investigative reflexology application Data collection forms will be filled out by an independent midwife who is not involved in the research One of the researchers SDA has approved international training and certification in the ability to apply foot reflexology techniques based on standard protocol
For the reflexology group first a 4-minute general massage will be applied to each foot then a 2-minute specific reflexology will be applied in the form of rotational pressures to each point of the pelvis sacrum uterus and solar plexus The application will take approximately 20-30 minutes These points were agreed upon by experts in reflexology as effective points in reducing pain and anxiety The control group will receive only general massage on each foot for 4 minutes
Statistical analysis will be performed using IBM SPSS Statistic 290 IBM Corp Armonk NY USA Descriptive statistical methods number percentage mean standard deviation will be used in the evaluation of socio-demographic data When the data is found to be suitable for normal distribution parametric tests chi-square T test etc will be used to compare categorical variables and when the data is not found to be suitable for normal distribution non-parametric tests Mann-Whitney U Test will be used Statistical significance level will be accepted as p005
Hypothesiss
H0 There is no difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair
H1 There is a difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair
Type of Research This study was designed as a randomized controlled experimental study
In order to determine the sample size in the study it was calculated according to the research conducted by Sharifi et al 2022 Considering the sample size in the R pwrss Statistical Power and Sample Size Calculation Tools program a type 1 alpha error of 005 and a power of 080 it was calculated that the study group should be at least 32 in the reflexology group and 32 in the control group Considering the confounding variables it was planned to recruit 25 more participants for each group and therefore it was decided to recruit 40 participants per group 80 participants in total
The participants included in the study will be divided into two groups by determining which group they will be included in from the website called Random List a random number generation program Thus each participants number and group number will be determined and recorded
Research data will be collected using the Participant Information Form VAS Visual Analog Scale and McGill Pain questionnaire to assess pain during episiotomy repair
Participant Information Form It was prepared by the researcher within the framework of the literature The form consists of a total of 14 questions that question womens socio-demographic and obstetrics-related information
VAS for Evaluation Pain during Episiotomy Repair The participant marks his or her own pain on a 10 cm ruler which is marked as no pain at one end and the most severe pain at the other end The participant is told that there are two endpoints and to mark any place between these points that matches the severity of the pain The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement The VAS is more sensitive than the simple descriptive scale
McGill Short Form for Assessment of Pain Following Episiotomy Repair The McGill Pain Questionnaire was developed by Melzack and Torgerson and is used to evaluate pain multidimensionally There are 15 criteria by which pain is evaluated 11 of these criteria are to evaluate the emotional dimension of pain and 4 are to evaluate the perceptual dimension of pain Assessment of pain was rated on an intensity scale from 0 to 3 0 none 1 mild 2 moderate 3 severe In the first part of the scale a total of three pain scores are obtained sensory pain score perceptual pain score and total pain score Sensory pain score ranges from 0-33 perceptual pain score ranges from 0-12 and total pain score ranges from 0-45 An increase in the score indicates that the pain also increases Second Part In this part there are five word groups ranging from mild pain to unbearable pain to determine the severity of the patients pain Third Part In the third part of MAS-CF the patients current pain intensity was evaluated using a visual comparison scale
Application of Research After obtaining the necessary ethics committee and institutional permissions to conduct the research the institution will be visited and participants who gave birth normally with episiotomy and meet the inclusion criteria for the study will be interviewed Data will be collected by the researcher in the hospital delivery room Women will be informed about the research and the purpose of the research will be explained Those who agree to participate in the research will be asked to read and sign the Informed Consent Form Participants who meet the criteria will be divided into reflexology and control groups The website called httpswwwrandomlistscom a random number generation program will be used to determine the selection process Thus each participants number and group number will be determined and recorded Episiotomy repairs will be performed by the same midwife We were going to do another investigative reflexology application Data collection forms will be filled out by an independent midwife who is not involved in the research One of the researchers SDA has approved international training and certification in the ability to apply foot reflexology techniques based on standard protocol
For the reflexology group first a 4-minute general massage will be applied to each foot then a 2-minute specific reflexology will be applied in the form of rotational pressures to each point of the pelvis sacrum uterus and solar plexus The application will take approximately 20-30 minutes These points were agreed upon by experts in reflexology as effective points in reducing pain and anxiety The control group will receive only general massage on each foot for 4 minutes
Statistical analysis will be performed using IBM SPSS Statistic 290 IBM Corp Armonk NY USA Descriptive statistical methods number percentage mean standard deviation will be used in the evaluation of socio-demographic data When the data is found to be suitable for normal distribution parametric tests chi-square T test etc will be used to compare categorical variables and when the data is not found to be suitable for normal distribution non-parametric tests Mann-Whitney U Test will be used Statistical significance level will be accepted as p005
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