The Effects of Acupressure Applied to the Primiparous During Episiotomy

NCT ID: NCT06552104

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-30

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.

Conditions

Episiotomy Wound; Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ACUPRESSURE

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.

Group Type: EXPERIMENTAL

ACUPRESSURE APPLI ACUPRESSURE APPLICATION

Intervention Type: 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).

Control group

control groups Control group standard care group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ACUPRESSURE APPLI ACUPRESSURE APPLICATION

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Esra SABANCI BARANSEL

OTHER

Sponsor Role: lead

Responsible Party

Esra SABANCI BARANSEL

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Esra Sabancı baransel

Malatya, Malatya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/ 4576

Identifier Type: -

Identifier Source: org_study_id