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Completed

NCT Number: NCT06552104

The Effects of Acupressure Applied to the Primiparous During Episiotomy

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.

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Key information

Conditions

Episiotomy Wound Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Esra Sabancı baransel

Malatya, 44280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. VAS

    Time frame: 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 outcomes

  1. STAI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Esra SABANCI BARANSEL

Other

Registry information

Official study title

The Effects of Acupressure Applied to the Primiparous During Episiotomy Repair on Pain and Anxiety Levels

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 13, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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