The Effects of Acupressure Applied to the Primiparous During Episiotomy

NCT06552104 | Completed

• 1 other identifier: 2023/ 4576
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Episiotomy Wound; Pain; Anxiety

Keywords

Acupressure; episiotomy; primiparous

Outcome Measures

Primary Outcomes (1)

• VAS

  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

  Change inbreastfeeding self-efficacy levels at 6 weeks change in pain after acupressure

Secondary Outcomes (1)

• STAI

  Change inbreastfeeding self-efficacy levels at 6 weeks change in anxiety after acupressure

Study Arms (2)

ACUPRESSURE

EXPERIMENTAL

In the study, acupressure was applied to the LI4 and HT7 points of the women for approximately 8-11 minutes during the episiotomy repair by BI, one of the researchers who has an acupressure application certificate. The researcher received training and certification in acupressure techniques before starting the intervention.During the episiotomy repair, acupressure was applied by the researcher twice in total. The first acupressure application was started with the first episiotomy suture being placed during the episiotomy repair (with the start of the internal perineal suturing). The second acupressure application was started with the end of the internal perineal suture and the first episiotomy suture of the skin suture. Each application was applied for approximately 4-6 minutes.

Behavioral: ACUPRESSURE APPLI ACUPRESSURE APPLICATION

Control group

NO INTERVENTION

control groups Control group standard care group

Interventions

ACUPRESSURE APPLI ACUPRESSURE APPLICATION BEHAVIORAL

Pre-test data were collected from participants who met the inclusion criteria and volunteered to participate in the study by researcher BI in the LDP rooms during the latency period of labor. Post-test data were obtained by the same researcher 16 hours after the cesarean section. Data were obtained using the Personal Information Form, Episiotomy Evaluation Form (EEF), Visual Analog Scale (VAS), and Spielberger Manual for State-Trait Anxiety Inventory (STAI).

ACUPRESSURE

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Episiotomy is performed on women who have given birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Esra SABANCI BARANSEL: lead

Study Sites (1)

Esra Sabancı baransel

Malatya, Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 13, 2024
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 30, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)