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

NCT07323758 | Not Yet Recruiting DMC

• 1 other identifier: 16.05.2025/155-58
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain; Anxiety; Patient Satisfaction

Keywords

pain; anxiety; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale

  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

  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

  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

Study Arms (3)

Music group

EXPERIMENTAL

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

Gum Chewing group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Music BEHAVIORAL

No studies in the literature have investigated the use of music and chewing gum during episiotomy repair, nor the difference between them.

Music group

Gum Chewing BEHAVIORAL

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.

Gum Chewing group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: POSTPARTUM WOMEN
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders; Patient Satisfaction

Interventions

Music Therapy; Chewing Gum

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Seda KARAÇAY YIKAR, DOCTOR

  Cukurova University

  STUDY CHAIR

• Evşen NAZİK, professor

  Cukurova University

  STUDY CHAIR

• Fikriye I ADIGÜZEL, Doctor

  Adana City Training and Research Hospital

  STUDY CHAIR

• Ayşe S AKBAY KISA, research ass

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe S AKBAY KISA, research ass

CONTACT

90 5435872734; ayse.sevim.32@gmail.com

Seda S KARAÇAY YIKAR, Doctor

CONTACT

05416265614; syikar@cu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: The study will be conducted as a three-group randomized controlled study to determine the effects of music and chewing gum on pain, anxiety, and patient satisfaction during the episiotomy repair procedure. 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 number (1, 2, and 3) will be determined by drawing lots. To ensure randomization in the study, numbers equal to the sample size (1, 2, 3, 4, 5, etc.) will be entered on the website www.random.org/ and divided into three groups, creating a random number table. The numbers in the columns determined on the website random.org/ will then be entered in the diagram below the group number determined by drawing lots. Pregnant women arriving at the delivery room and enrolled in the study will be assigned to the group they were in (Music Group, Chewing Gum Group, and Control Group) in the order they arrived. Intervention Group Implementation Step

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion: January 20, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share