Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649124
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2022-11-24
Brief Title:
Nonpharmacological Method for Relief of Episiotomy
Sponsor:
Kocaeli University
Organization:
Kocaeli University
Study Overview
Official Title:
The Effect of Acupressure on Perineal Pain Level in Primiparous Women With Episiotomy A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-05
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 study is a randomized controlled study to evaluate the effectiveness of acupressure applied to primiparous pregnant women who underwent episiotomy in the early postpartum period
The research was carried out between August 2022 and November 2022 at Düzce University Health Practice and Research Center with mothers who gave vaginal birth The research was carried out with two groups as acupressure and control groups The sample number was calculated using the GPower 3192 program and the acupressure group 30 and the control group 30 It was collected the research data with the Introductory Information Form and Visual Analog Scale The participants in the acupressure group were interviewed at the 3rd and 5th hours after birth The application announcement was made and they were allowed to sign the voluntary consent form The VAS was filled by the participant before the application Acupressure was applied to SP6 ST36 and LI4 points for a total of 12 minutes After the application the VAS was filled again by the participant
No application was made to the control group The data of the research was evaluated using the Statistical Package 220 program for Social Sciences In the evaluation of the data descriptive statistics was given as percentage arithmetic meanstandard deviation median and minimum-maximum values Independent two-sample t-test was used for normally distributed variables and Mann-Whitney U test was used for non-normally distributed variables Pearson Correlation test was applied to determine the relationship between the pain intensity of the acupressure group and the tests and to determine the relationship between the tests Statistical significance level was accepted as p005
The research was carried out between August 2022 and November 2022 at Düzce University Health Practice and Research Center with mothers who gave vaginal birth The research was carried out with two groups as acupressure and control groups The sample number was calculated using the GPower 3192 program and the acupressure group 30 and the control group 30 It was collected the research data with the Introductory Information Form and Visual Analog Scale The participants in the acupressure group were interviewed at the 3rd and 5th hours after birth The application announcement was made and they were allowed to sign the voluntary consent form The VAS was filled by the participant before the application Acupressure was applied to SP6 ST36 and LI4 points for a total of 12 minutes After the application the VAS was filled again by the participant
No application was made to the control group The data of the research was evaluated using the Statistical Package 220 program for Social Sciences In the evaluation of the data descriptive statistics was given as percentage arithmetic meanstandard deviation median and minimum-maximum values Independent two-sample t-test was used for normally distributed variables and Mann-Whitney U test was used for non-normally distributed variables Pearson Correlation test was applied to determine the relationship between the pain intensity of the acupressure group and the tests and to determine the relationship between the tests Statistical significance level was accepted as p005
Detailed Description:
Aim This study was planned to examine the effect of acupuncture on perineal pain after episiotomy in the early postpartum period
Research hypothesis
H0 Acupressure application applied to pregnant women who underwent episiotomy in the postpartum period has no effect on reducing the level of perineal pain
H1 Acupressure application applied to pregnant women who underwent episiotomy in the postpartum period reduces the level of perineal pain
Type of Study This study was designed as a randomized controlled experimental study
Research Universe The population of the study consisted of participants who had vaginal birth had episiotomy and were primiparous postpartum between the 3rd and 5th hours of the early postpartum period in Düzce University Health Practice and Research Center The G- Power program was used to determine the sample of the study and it was planned to recruit a total of 60 participants 30 participants in the Acupressure group and 30 participants in the control group
Random number generation program Research It will be determined from Randomizers website and divided into two groups Thus the number of each mother and the group number were determined and recorded
Research data Participant Information Form VAS Visual Analog Scale for Evaluating perineal Pain
Exhibitor Information Form It was prepared by the researcher within the framework of the literature The form consists of a total of 31 questions questioning womens socio -demographic obstetric and perineal pain information It is applied to postpartum women on the 1st day after delivery
VAS Visual analog scale Evaluation of Perineal Pain The patient marks his or her pain on a 10 cm ruler with no pain at one end and the most severe pain at the other The patient is told that there are two endpoints and to mark any place between these points appropriate to the severity of the pain The distance between the onset of painlessness and this point marked by the patient is measured in centimeters and recorded 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
Application Procedure of the Study After obtaining the necessary permissions from the ethics committee and the institution for the implementation of the study participants who had a vaginal delivery and met the inclusion criteria of the study were interviewed by the institution Participants were informed that they could participate in the study without affecting the care received at the hospital and that they could leave the study at any time and their voluntary consent was obtained After the participants were included in the study they were assigned to the study groups according to the electronic randomization table The data were collected by face-to-face interviews by the researcher working in the delivery room of the hospital VAS Visual Analog Scale was filled in by the participants to evaluate postpartum perineal pain The VAS Visual analog scale in which perineal pain was evaluated was filled in by the participants in the postpartum acupressure group at the 3rd and 5th hours before and after the application No application was made to the control group other than routine applications
Acupressure Application Technique An environment where privacy can be protected and there are no external stimuli was prepared for the participants The application started by leaving the application points open and choosing the most comfortable position for the participants For this study 3 points 6 points in total on both sides from each point were determined and these points are SP6 the 6th point of the spleen meridian LI4 the 4th point of the large intestine meridian and ST36 the 36th point of the stomach meridian In addition expert opinion was taken to determine the points The practitioner will respectively apply circular motions to the points and then apply pressure within two minutes Although there is a difference in the order of use of the determined acupuncture points this study was performed symmetrically to the LI4 SP6 and ST36 points respectively The practitioner will have a stopwatch to control the time
Large Intestine Meridian Point 4 He Gu LI4
Position It is the point where the cambered muscle group is located when the thumb and index finger are brought closer together In other words it corresponds to the midpoint of the metacarpal bone of the index finger
Application Technique Press the point with thumbmiddle finger in a circular or up and down direction along the meridian line for 2 minutes Work on 2 points on both hands separately or simultaneously Signs of the Spot Although this area is often used for face headache and toothache it is also a frequently preferred area to increase alertness and reduce fatigue
Indications Although this area is generally used for face head and toothache it is also a frequently preferred area to increase alertness and reduce fatigue
Spleen Meridian 6th Point Sanyinjiao SP6
Location It is located on the inside of the shinbone four fingers above the ankle
Application Technique Press the point with thumbmiddle finger in a circular or up and down direction along the meridian line for 2 minutes Work on 2 points on both legs separately or simultaneously
Symptoms of the Point This point which is generally used for urological and pelvic problems menstrual pain and insomnia is also preferred in various studies to reduce fatigue
Stomach Meridian 36th Point ST36
Location It is located in the anterior part of the tibia four fingers below the patella
Application Technique Press the point with thumbmiddle finger in a circular or up and down direction along the meridian line for 2 minutes Work on 2 points on both legs separately or simultaneously
Spot Symptoms Provides good digestive power and is effective in relieving constipation diarrhea and bloating It is a vital energy point in the prevention of diabetes which can be caused by increased heartburn
Application to Acupressure Group
The participants in this group were interviewed at the 3rd and 5th hours after birth The application was announced and the voluntary consent form was signed
Participant Information Form was filled by the researcher through face-to-face interview
The VAS to be applied to evaluate perineal pain at the 3rd and 5th hours after delivery was filled out by the participant
The total duration of the application in which SP6 ST36 and LI4 scores were applied for 2 minutes was 12 minutes
After the application the VAS Perineal Pain Evaluation form was filled by the participant
The participant was informed that the study was completed
Application to the Control Group
The participants in this group were interviewed at the 3rd and 5th hours after birth The application was announced and the voluntary consent form was signed
Participant Information Form was filled by the researcher through face-to-face interview
3 VAS Visual analog scale Evaluation of Perineal Pain was requested at 5th and 5th hours
No application other than routine applications
Statistical and Analytical Methods
Statistical analysis will be performed using the IBM SPSS Statistic 220 IBM Corp Armonk NY USA program Descriptive statistical methods number percentage mean standard deviation will be used in the evaluation of sociodemographic data Parametric tests chi-square T test etc and non-paramedic tests Mann-Whitney U Test Kruskal Wallis etc will be used in the comparison of categorical variables when it is seen that the data are suitable for normal distribution will be used when it is not suitable for a normal distribution P significance level will be accepted as 005
Research hypothesis
H0 Acupressure application applied to pregnant women who underwent episiotomy in the postpartum period has no effect on reducing the level of perineal pain
H1 Acupressure application applied to pregnant women who underwent episiotomy in the postpartum period reduces the level of perineal pain
Type of Study This study was designed as a randomized controlled experimental study
Research Universe The population of the study consisted of participants who had vaginal birth had episiotomy and were primiparous postpartum between the 3rd and 5th hours of the early postpartum period in Düzce University Health Practice and Research Center The G- Power program was used to determine the sample of the study and it was planned to recruit a total of 60 participants 30 participants in the Acupressure group and 30 participants in the control group
Random number generation program Research It will be determined from Randomizers website and divided into two groups Thus the number of each mother and the group number were determined and recorded
Research data Participant Information Form VAS Visual Analog Scale for Evaluating perineal Pain
Exhibitor Information Form It was prepared by the researcher within the framework of the literature The form consists of a total of 31 questions questioning womens socio -demographic obstetric and perineal pain information It is applied to postpartum women on the 1st day after delivery
VAS Visual analog scale Evaluation of Perineal Pain The patient marks his or her pain on a 10 cm ruler with no pain at one end and the most severe pain at the other The patient is told that there are two endpoints and to mark any place between these points appropriate to the severity of the pain The distance between the onset of painlessness and this point marked by the patient is measured in centimeters and recorded 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
Application Procedure of the Study After obtaining the necessary permissions from the ethics committee and the institution for the implementation of the study participants who had a vaginal delivery and met the inclusion criteria of the study were interviewed by the institution Participants were informed that they could participate in the study without affecting the care received at the hospital and that they could leave the study at any time and their voluntary consent was obtained After the participants were included in the study they were assigned to the study groups according to the electronic randomization table The data were collected by face-to-face interviews by the researcher working in the delivery room of the hospital VAS Visual Analog Scale was filled in by the participants to evaluate postpartum perineal pain The VAS Visual analog scale in which perineal pain was evaluated was filled in by the participants in the postpartum acupressure group at the 3rd and 5th hours before and after the application No application was made to the control group other than routine applications
Acupressure Application Technique An environment where privacy can be protected and there are no external stimuli was prepared for the participants The application started by leaving the application points open and choosing the most comfortable position for the participants For this study 3 points 6 points in total on both sides from each point were determined and these points are SP6 the 6th point of the spleen meridian LI4 the 4th point of the large intestine meridian and ST36 the 36th point of the stomach meridian In addition expert opinion was taken to determine the points The practitioner will respectively apply circular motions to the points and then apply pressure within two minutes Although there is a difference in the order of use of the determined acupuncture points this study was performed symmetrically to the LI4 SP6 and ST36 points respectively The practitioner will have a stopwatch to control the time
Large Intestine Meridian Point 4 He Gu LI4
Position It is the point where the cambered muscle group is located when the thumb and index finger are brought closer together In other words it corresponds to the midpoint of the metacarpal bone of the index finger
Application Technique Press the point with thumbmiddle finger in a circular or up and down direction along the meridian line for 2 minutes Work on 2 points on both hands separately or simultaneously Signs of the Spot Although this area is often used for face headache and toothache it is also a frequently preferred area to increase alertness and reduce fatigue
Indications Although this area is generally used for face head and toothache it is also a frequently preferred area to increase alertness and reduce fatigue
Spleen Meridian 6th Point Sanyinjiao SP6
Location It is located on the inside of the shinbone four fingers above the ankle
Application Technique Press the point with thumbmiddle finger in a circular or up and down direction along the meridian line for 2 minutes Work on 2 points on both legs separately or simultaneously
Symptoms of the Point This point which is generally used for urological and pelvic problems menstrual pain and insomnia is also preferred in various studies to reduce fatigue
Stomach Meridian 36th Point ST36
Location It is located in the anterior part of the tibia four fingers below the patella
Application Technique Press the point with thumbmiddle finger in a circular or up and down direction along the meridian line for 2 minutes Work on 2 points on both legs separately or simultaneously
Spot Symptoms Provides good digestive power and is effective in relieving constipation diarrhea and bloating It is a vital energy point in the prevention of diabetes which can be caused by increased heartburn
Application to Acupressure Group
The participants in this group were interviewed at the 3rd and 5th hours after birth The application was announced and the voluntary consent form was signed
Participant Information Form was filled by the researcher through face-to-face interview
The VAS to be applied to evaluate perineal pain at the 3rd and 5th hours after delivery was filled out by the participant
The total duration of the application in which SP6 ST36 and LI4 scores were applied for 2 minutes was 12 minutes
After the application the VAS Perineal Pain Evaluation form was filled by the participant
The participant was informed that the study was completed
Application to the Control Group
The participants in this group were interviewed at the 3rd and 5th hours after birth The application was announced and the voluntary consent form was signed
Participant Information Form was filled by the researcher through face-to-face interview
3 VAS Visual analog scale Evaluation of Perineal Pain was requested at 5th and 5th hours
No application other than routine applications
Statistical and Analytical Methods
Statistical analysis will be performed using the IBM SPSS Statistic 220 IBM Corp Armonk NY USA program Descriptive statistical methods number percentage mean standard deviation will be used in the evaluation of sociodemographic data Parametric tests chi-square T test etc and non-paramedic tests Mann-Whitney U Test Kruskal Wallis etc will be used in the comparison of categorical variables when it is seen that the data are suitable for normal distribution will be used when it is not suitable for a normal distribution P significance level will be accepted as 005
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