Effects of Music Application and Gum Chewing on Pain, Anxiety, and Patient Satisfaction During Episiotomy Repair

January 6, 2026 updated by: Ayşe Sevim AKBAY KISA, Suleyman Demirel University

Lacerations and episiotomies are serious procedures requiring surgical stitches. Therefore, pain occurs during episiotomy repair. Pain during episiotomy repair also causes anxiety, which in turn exacerbates pain. The goal of pain management is to alleviate pain without experiencing side effects. Midwives and nurses responsible for labor management play an active role in the use of nonpharmacological interventions to manage pain and anxiety during episiotomy repair.

No studies in the literature have been found that combine music and chewing gum during episiotomy repair. This study aims to determine the effects of music and chewing gum during episiotomy repair on pain, anxiety, and patient satisfaction.

This study will be to determine the effects of music and chewing gum during episiotomy repair on pain, anxiety, and patient satisfaction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Midwives and nurses responsible for labor management play an active role in the use of nonpharmacological interventions to manage pain and anxiety during episiotomy repair.

This study will be a three-group randomized controlled trial to determine the effects of music and chewing gum during episiotomy repair on pain, anxiety, and patient satisfaction.

Research Location and Time Research data collection will be conducted in the delivery room at Adana City Training and Research Hospital between December 2025 and February 2026.

2.3. Research Population and Sample The research population will consist of women who underwent vaginal delivery and episiotomy repair in the delivery room at Adana Training and Research Hospital who meet the study criteria. The research sample will be calculated using a power analysis following a preliminary study (10 music groups, 10 chewing gum groups, and 10 control groups)

Data Collection Tools Data will be a Pregnancy Information Form, a Labor Monitoring Form, Visual Analog Scale (VAS) Pain Score , the State Anxiety Inventory and the Patient Perception of Nursing Care Scale.

Data Collection: Pregnant women participating in the study will be administered an informed consent form, a Pregnancy Information Form, and a Labor Monitoring Form during the first stage of labor. In our study, the VAS pain score will be administered four times: before the episiotomy, during the internal episiotomy repair (suturing at the hymenal ring level), during the external episiotomy repair, and one hour after the episiotomy.

Research Implementation Process After obtaining written and verbal consent from the pregnant women, they will be assigned to the previously determined groups through randomization.

Randomization The name of each group (Music Group, Chewing Gum Group, and Control Group) will be written on a piece of paper, and the group numbers (1, 2, and 3) will be determined by lottery. To ensure randomization in the study, a random number table will be created by entering the number of samples (sample numbers 1, 2, 3, 4, 5, etc.) on the site www.random.org/ and dividing the participants into three groups.

Intervention Group Implementation Steps The music and chewing gum application and other data forms will be introduced to the pregnant women at the beginning of the active phase. Pregnant women participating in the study will be asked to choose relaxing music from an international platform that utilizes the sounds of relaxing music therapies.

Music group protocol: Women in the music group will listen to their preferred music using an connected to speakers in the delivery room between the beginning and end of the episiotomy repair (15-20 minutes).

Chewing Gum group protocol: Women assigned to the chewing gum group will chew plain gum between the beginning and end of the episiotomy repair (15-20 minutes).

Control group implementation steps Pregnant women in the control group will be administered an informed consent form, a Pregnancy Information Form, and a Labor Monitoring Form during the active phase of the first stage.

Data Evaluation Data obtained from the study will be analyzed using the Statistical Package for Social Sciences (SPSS 23.0) for Windows.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Seda S KARAÇAY YIKAR, Doctor
  • Phone Number: 05416265614
  • Email: syikar@cu.edu.tr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Study participation criteria

    • Women aged 18-49,
    • Primiparous,
    • Having a medio-lateral episiotomy,
    • Having a singleton pregnancy,
    • Vertex presentation,
    • Having given birth vaginally,
    • Having an episiotomy length of 4-5 cm,
    • Having an uncomplicated newborn,
    • Volunteering to participate in the study,
    • Being able to speak and understand Turkish.

Exclusion Criteria:

  • Women who experienced deep lacerations (anal sphincter injuries, 3rd and 4th degree lacerations) during labor,
  • Those who underwent operative delivery (with vacuum or forceps),
  • Those with visual, hearing, or sensory impairments,
  • Those who were not diagnosed with a psychiatric disorder but had problems,
  • Those diagnosed with a high-risk pregnancy,
  • Those who had any signs of infection, such as vaginal redness or swelling,
  • Those who developed complications during any stage of labor,
  • Women with chronic illnesses (diabetes mellitus, thyroid disease, and hypertension) will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music group
Women in the music group will listen to their preferred music using an Music Headphones connected to speakers in the delivery room between the beginning and end of the episiotomy repair (15-20 minutes).
Behavioral: Music
No studies in the literature have investigated the use of music and chewing gum during episiotomy repair, nor the difference between them.
Experimental: Gum Chewing group

Women in the music group will listen to their preferred music using an Music Headphones connected to speakers in the delivery room between the beginning and end of the episiotomy repair (15-20 minutes).

Gum group protocol: Women assigned to the gum group will chew plain gum between the beginning and end of the episiotomy repair (15-20 minutes). They will be asked to chew the same brand of easy-to-chew, sugar-free gum that does not contain sorbitol or xylitol. Sugar-free gum is preferred to avoid the risk of GI problems if swallowed with sorbitol-containing gum, and the risk of diarrhea if consumed in excess with xylitol. Given the risk of aspiration while chewing gum, the woman will be positioned in a semi-fowler position.
Behavioral: Gum Chewing
Women assigned to the gum group will chew plain gum between the beginning and end of the episiotomy repair (15-20 minutes). They will be asked to chew the same brand of easy-to-chew, sugar-free gum that does not contain sorbitol or xylitol. Sugar-free gum is preferred to avoid the risk of GI problems if swallowed with sorbitol-containing gum, and the risk of diarrhea if consumed in excess with xylitol. Given the risk of aspiration while chewing gum, the woman will be positioned in a semi-fowler position.
No Intervention: Control group
Pregnant women in the control group will be administered an informed consent form, a pregnant information form, and a labor monitoring form during the active phase of the first stage. Pregnant women in the control group will not deviate from routine procedures performed in the delivery room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: The research period for a participant takes approximately 1 day
The Visual Analog Scale (VAS) is used to assess pain intensity. The scale can be scored from 0 to 10 To be collected through a survey. The collected data were planned to be analyzed using SPSS with mean and standard deviation.
The research period for a participant takes approximately 1 day
The PATIENT'S PERCEPTION SCALE
Time Frame: The research period for a participant takes approximately 1 day
The PATIENT'S PERCEPTION SCALE scale was developed by Dopier et al. It was developed to measure patients' perceptions of nursing care and their satisfaction with it. The five-point Likert-type scale includes 15 statements regarding the quality of nursing care. Thus, The scale can be scored from 15 to 75. The scale can be scored from 20 to 80. The collected data were planned to be analyzed using SPSS with mean and standard deviation.
The research period for a participant takes approximately 1 day
The State Anxiety Scale
Time Frame: The research period for a participant takes approximately 1 day
The State Anxiety Scale (SAAS) was developed by Spielberger et al. The State Anxiety Scale has 20 items. It is used to measure anxiety symptoms. The items describing emotions and behaviors in the scale are scored on a 4-point Likert-type scale: "(1) Not at all," "(2) A little," "(3) A lot," and "(4) Completely." The scale can be scored from 20 to 80. The scale can be scored from 20 to 80 The collected data were planned to be analyzed using SPSS with mean and standard deviation.
The research period for a participant takes approximately 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Investigators

  • Study Chair: Seda KARAÇAY YIKAR, DOCTOR, Çukurova University
  • Study Chair: Evşen NAZİK, professor, Çukurova University
  • Study Chair: Fikriye I ADIGÜZEL, Doctor, Adana City Training and Research Hospital
  • Principal Investigator: Ayşe S AKBAY KISA, research ass, Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

May 28, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.05.2025/155-58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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