Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
Sponsor:
Uskudar University
Organization:
Uskudar University
Study Overview
Official Title:
The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
Status:
NOT_YET_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 study was planned to evaluate the effect of LI4 acupressure application on perineal pain and postpartum comfort during episiotomy repair Our study was designed as a randomized controlled single-blind and placebo design experimental study The study is planned to be conducted in the maternity ward of Istanbul SBU Kanuni Sultan Süleyman Training and Research Hospital between May 1 2024 and October 20 2025 The sample of the study will consist of a total of 90 pregnant women who were hospitalized in the maternity ward and agreed to participate in the study During the episiotomy repair the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 seconds in succession and a 10-second break will be taken A different point 1-15 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be pressed No intervention will be applied to the control group
Detailed Description:
Background Pain relief in the intrapartum period is important for maternal-fetal health Studies in the literature have generally focused on the first stage of labor When the labor process is considered as a whole women may also experience pain during episiotomy repair In recent years traditional methods have become more preferred due to the side effects of pharmacologic treatments to relieve pain symptoms Acupressure one of the traditional methods is used to relieve pain and various symptoms by applying pressure on acupuncture points with manual techniques In the literature LI4 acupressure is applied to relieve pain symptoms caused by various reasons However among the studies reviewed no study was found to investigate the effect of LI4 acupressure application on perineal pain perceived during episiotomy repair and postpartum comfort level
Objective The study was planned to evaluate the effect of LI4 acupressure on perineal pain and postpartum comfort during episiotomy repair
Materials and Methods Our study was designed as a randomized controlled single-blind placebo-designed experimental study The study will be conducted in the maternity ward of Istanbul SBÜ Kanuni Sultan Süleyman Training and Research Hospital between May 1 2024 and October 20 2025 The sample of the study will consist of a total of 90 pregnant women experimental group 30 control group 30 placebo group 30 who were hospitalized in the maternity ward and agreed to participate in the study During the episiotomy repair the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession followed by a 10 s break The procedure will start with the first suturing Vital signs will be taken just before the first suturing and after the suturing is completed A different point 1-15 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed No intervention will be applied to the control group Data will be obtained using the Pregnancy Identification Form Visual Comparison Scale Postpartum Comfort Scale Labor Monitoring Form and McGill Pain Scale Short Form The data obtained from the study will be analyzed in SPSS 23 statistical program in computer environment In the evaluation of the data mean standard deviation minimum and maximum values frequency and percentage calculations t-test and chi-square test will be used
Objective The study was planned to evaluate the effect of LI4 acupressure on perineal pain and postpartum comfort during episiotomy repair
Materials and Methods Our study was designed as a randomized controlled single-blind placebo-designed experimental study The study will be conducted in the maternity ward of Istanbul SBÜ Kanuni Sultan Süleyman Training and Research Hospital between May 1 2024 and October 20 2025 The sample of the study will consist of a total of 90 pregnant women experimental group 30 control group 30 placebo group 30 who were hospitalized in the maternity ward and agreed to participate in the study During the episiotomy repair the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession followed by a 10 s break The procedure will start with the first suturing Vital signs will be taken just before the first suturing and after the suturing is completed A different point 1-15 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed No intervention will be applied to the control group Data will be obtained using the Pregnancy Identification Form Visual Comparison Scale Postpartum Comfort Scale Labor Monitoring Form and McGill Pain Scale Short Form The data obtained from the study will be analyzed in SPSS 23 statistical program in computer environment In the evaluation of the data mean standard deviation minimum and maximum values frequency and percentage calculations t-test and chi-square test will be used
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