The Effects of Acupressure Applied to the Primiparous During Episiotomy

Not Applicable

Completed

• Conditions: Pain; Anxiety; Episiotomy Wound

• Registration Number: NCT06552104
• Lead Sponsor: Esra SABANCI BARANSEL

Brief Summary

This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.

The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.

Detailed Description

Introduction: This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.

Methods: The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• Being 18 or older,
• having a single healthy newborn,
• Giving spontaneous birth through a medio-lateral episiotomy incision,
• No signs of infection such as vaginal redness or swelling,
• Women with full and healthy tissue integrity in the area where acupressure will be applied.

Exclusion Criteria

• The need to use unusual lidocaine during episiotomy repair (lidocaine 2% higher than 5 ml),
• having any postpartum complications (such as bleeding, hypertension).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	Change inbreastfeeding self-efficacy levels at 6 weeks change in pain after acupressure	The VAS was used to assess the pain severity of the incision site. The VAS is a scale created in the range of 0-100 mm. According to the scale, a score of 0 mm indicates that the pain is not severe at all, and a score of 100 mm indicates that the pain is extremely severe

Secondary Outcome Measures

Name	Time	Method
STAI	Change inbreastfeeding self-efficacy levels at 6 weeks change in anxiety after acupressure	STAI was developed by Spielberger et al. (1970) to measure state and trait anxiety levels, and its adaptation, validity, and reliability study was conducted by Öner and Le Compte (1983) for the Turkish society. The STAI is a 20-item inventory, and a high score indicates that the individual has a high level of anxiety, while a low score indicates that the anxiety level is low. The lowest score that can be obtained from the scale is 20, and the highest score is 80. This scale, which is a 4-point Likert-type scale, is graded as Not at All, A Little, A Lot, and Extremely.

Trial Locations

Locations (1)

Esra Sabancı baransel; 🇹🇷 Malatya, Turkey