PainNCT07323758
Effects of Music Application and Gum Chewing on Pain, Anxiety, and Patient Satisfaction During Episiotomy Repair
A study testing Music and Gum Chewing in people with Pain and Anxiety, run by Suleyman Demirel University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Patient Satisfaction
- What is being tested?
- Music and Gum Chewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to 28 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study participation criteria
- Women aged 18-49,
- Primiparous,
- Having a medio-lateral episiotomy,
- Having a singleton pregnancy,
- Vertex presentation,
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Pain, Anxiety, Patient Satisfaction
- Being tested
- Music, Gum Chewing
- Keywords
- pain, anxiety, Patient Satisfaction
- Medical subject headings
- Pain, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
No studies in the literature have investigated the use of music and chewing gum during episiotomy repair, nor the difference between them.
Gum ChewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The research period for a participant takes approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startJan 2026 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sevim AKBAY KISA, Suleyman Demirel University
- Investigators
- Seda KARAÇAY YIKAR, DOCTOR, Study chair, Cukurova UniversityEvşen NAZİK, professor, Study chair, Cukurova UniversityFikriye I ADIGÜZEL, Doctor, Study chair, Adana City Training and Research HospitalAyşe S AKBAY KISA, research ass, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323758
- Sponsor's protocol ID
- 16.05.2025/155-58
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Application and Gum Chewing on Pain, Anxiety, and Patient Satisfaction During Episiotomy Repair
- ClinicalTrials.gov ID
- NCT07323758
- Acronym / sponsor ID
- 16.05.2025/155-58
- Conditions
- Pain, Anxiety, Patient Satisfaction
- Keywords
- pain, anxiety, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Behavioral: MusicWomen 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 Chewing group | Experimental | Behavioral: Gum ChewingWomen 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Study participation criteria
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicNo studies in the literature have investigated the use of music and chewing gum during episiotomy repair, nor the difference between them. | Behavioural | Music group |
| Gum ChewingWomen 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. | Behavioural | Gum Chewing group |
Primary outcome
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 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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda KARAÇAY YIKAR, DOCTOR study chair
Cukurova University
Evşen NAZİK, professor study chair
Cukurova University
Fikriye I ADIGÜZEL, Doctor study chair
Adana City Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Music and Gum Chewing in people with Pain and Anxiety, run by Suleyman Demirel University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe S AKBAY KISA, research ass (90 5435872734, ayse.sevim.32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: The research period for a participant takes approximately 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.