PostpartumNCT07786558
Ukulele Music on Pain, Anxiety, and Postpartum Comfort
A study testing Live Ukulele Music in people with Postpartum, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine whether listening to live ukulele music after cesarean delivery can help reduce pain-related distress and anxiety and improve comfort in women who have given birth by cesarean section for the first time. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum
- What is being tested?
- Live Ukulele Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2025to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women who have undergone cesarean delivery under spinal anesthesia
- No chronic disease
- Turkish-speaking
- Able to communicate effectively
- Willing to participate voluntarily and provide written informed consent
Who cannot join
- Hearing impairment
- Cesarean delivery performed under epidural or general anesthesia
- Development of postoperative complications
- Requirement for additional analgesics beyond routine postoperative treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ukulele Music on Pain, Anxiety, and Postpartum Comfort in Women Who Underwent Cesarean Delivery
This study aims to examine whether listening to live ukulele music after cesarean delivery can help reduce pain-related distress and anxiety and improve comfort in women who have given birth by cesarean section for the first time.
Women participating in the study will be randomly assigned to either a ukulele music group or a routine care group. Women in the ukulele music group will listen to live ukulele music for 30 minutes at 24 hours after cesarean delivery. Women in the routine care group will receive the usual care provided by the hospital.
The study will compare the two groups in terms of pain-related thoughts and distress, postpartum anxiety, and overall comfort during the early postpartum period. The findings may help determine whether live ukulele music can be used as a simple, non-drug approach to support women during recovery after cesarean delivery.
Read the detailed description
Cesarean delivery is a common surgical method of childbirth and may be associated with pain, anxiety, psychological stress, and difficulties in adapting to the early postpartum period. Non-pharmacological approaches may help support women's comfort and psychological well-being during this period.
This study evaluates whether listening to live ukulele music after cesarean delivery can reduce pain catastrophizing and postpartum-specific anxiety and improve postpartum comfort in primiparous women. Participants are randomly assigned to either a ukulele music group or a routine care group.
Women in the intervention group receive a 30-minute live ukulele music session at 24 hours after cesarean delivery. The same standardized melody is performed by the researcher in the participant's room. Women in the control group receive routine postoperative care without an additional intervention during the study assessment period.
The effects of the intervention are evaluated using standardized questionnaires assessing pain catastrophizing, postpartum-specific anxiety, and postpartum comfort. The study aims to determine whether a brief, non-pharmacological music intervention may be a feasible complementary approach to support women's psychological well-being and pain management during the early postpartum period.
The study is intended to provide information that may be useful to women, families, nurses, midwives, and other healthcare professionals interested in supportive and non-pharmacological approaches to postpartum care.
- Conditions
- Postpartum
- Being tested
- Live Ukulele Music
- Keywords
- Anxiety; Cesarean Delivery; Music Therapy; Pain; Postpartum Comfort; Ukulele
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Ukulele MusicBehavioural
Women who were admitted to the postoperative unit and met the eligibility criteria were assessed by the researcher. Eligible women were provided with written and verbal information about the purpose of the study, the intervention procedures, ethical and institutional permissions, and the confidentiality of personal information. Written informed consent was obtained from women who agreed to participate in the study. Participants were assigned to the intervention and control groups in a 1:1 ratio using a computer-generated randomization sequence created with the RANDOM.ORG Sequence Generator (RANDOM.ORG, 2026).
After the Informed Consent Form and Introductory Characteristics Questionnaire were administered to women assigned to the intervention group, the same standardized melody was performed live on the ukulele by the researcher for 30 minutes at 24 hours postoperatively. Following the intervention, the Postpartum Specific Anxiety Scale, Postpartum Comfort Scale, and Pain Catastrophizin
| Study group | Role | What they receive |
|---|---|---|
| Live Ukulele Music Group | Experimental | Participants assigned to this arm will receive a 30-minute live ukulele music intervention at 24 hours after cesarean delivery. The same standardized melody will be performed live by the researcher in the participant's room. Room temperature and lighting will be adjusted according to the participant's preferences, and the ukulele sound level will be maintained between 70 and 73 dB throughout the intervention. Following the intervention, participants will complete assessments of pain catastrophizing, postpartum-specific anxiety, and postpartum comfort. Receives: Behavioral: Live Ukulele Music |
| Routine Care Group | No intervention | Participants assigned to this arm will receive the routine care and treatment provided by the clinical unit throughout the postoperative period, with no additional intervention during the study assessment period. The same outcome assessments will be administered at 25-26 hours after cesarean delivery. After completion of data collection, participants in the control group will be offered the same ukulele melody for 30 minutes as an ethical consideration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Level
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item self-report instrument assessing rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating higher levels of pain catastrophizing. The outcome will be compared between the ukulele music intervention group and the routine care control group.
Measured: Between 25 and 26 hours postoperatively
Postpartum-Specific Anxiety Level
Postpartum-specific anxiety will be assessed using the Turkish version of the Postpartum Specific Anxiety Scale (PSAS). The scale consists of 47 items rated on a 4-point Likert scale, with higher total scores indicating higher levels of postpartum-specific anxiety. The outcome will be compared between the ukulele music intervention group and the routine care control group.
Measured: Between 25 and 26 hours postoperatively
Postpartum Comfort Level
Postpartum comfort will be assessed using the Postpartum Comfort Questionnaire (PPCQ), a 34-item instrument evaluating physical, psychospiritual, and sociocultural comfort. Total scores range from 34 to 170, with higher scores indicating higher levels of postpartum comfort. The outcome will be compared between the ukulele music intervention group and the routine care control group.
Measured: Between 25 and 26 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start5 Mar 2025
- Primary completion1 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned in a 1:1 ratio to either the ukulele music intervention group or the routine care control group. The intervention group will receive a 30-minute live ukulele music intervention at 24 hours after cesarean delivery, while the control group will receive routine postoperative care without an additional intervention during the study assessment period. Outcomes will be assessed after the intervention and compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Akın, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786558
- Sponsor's protocol ID
- 2024/17/647
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ukulele Music on Pain, Anxiety, and Postpartum Comfort in Women Who Underwent Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07786558
- Acronym / sponsor ID
- 2024/17/647
- Conditions
- Postpartum
- Keywords
- Anxiety; Cesarean Delivery; Music Therapy; Pain; Postpartum Comfort; Ukulele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 26 Aug 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.
This study aims to examine whether listening to live ukulele music after cesarean delivery can help reduce pain-related distress and anxiety and improve comfort in women who have given birth by cesarean section for the first time.
Women participating in the study will be randomly assigned to either a ukulele music group or a routine care group. Women in the ukulele music group will listen to live ukulele music for 30 minutes at 24 hours after cesarean delivery. Women in the routine care group will receive the usual care provided by the hospital.
The study will compare the two groups in terms of pain-related thoughts and distress, postpartum anxiety, and overall comfort during the early postpartum period. The findings may help determine whether live ukulele music can be used as a simple, non-drug approach to support women during recovery after cesarean delivery.
Detailed description
Cesarean delivery is a common surgical method of childbirth and may be associated with pain, anxiety, psychological stress, and difficulties in adapting to the early postpartum period. Non-pharmacological approaches may help support women's comfort and psychological well-being during this period.
This study evaluates whether listening to live ukulele music after cesarean delivery can reduce pain catastrophizing and postpartum-specific anxiety and improve postpartum comfort in primiparous women. Participants are randomly assigned to either a ukulele music group or a routine care group.
Women in the intervention group receive a 30-minute live ukulele music session at 24 hours after cesarean delivery. The same standardized melody is performed by the researcher in the participant's room. Women in the control group receive routine postoperative care without an additional intervention during the study assessment period.
The effects of the intervention are evaluated using standardized questionnaires assessing pain catastrophizing, postpartum-specific anxiety, and postpartum comfort. The study aims to determine whether a brief, non-pharmacological music intervention may be a feasible complementary approach to support women's psychological well-being and pain management during the early postpartum period.
The study is intended to provide information that may be useful to women, families, nurses, midwives, and other healthcare professionals interested in supportive and non-pharmacological approaches to postpartum care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the ukulele music intervention group or the routine care control group. The intervention group will receive a 30-minute live ukulele music intervention at 24 hours after cesarean delivery, while the control group will receive routine postoperative care without an additional intervention during the study assessment period. Outcomes will be assessed after the intervention and compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Live Ukulele Music Group | Experimental | Behavioral: Live Ukulele MusicParticipants assigned to this arm will receive a 30-minute live ukulele music intervention at 24 hours after cesarean delivery. The same standardized melody will be performed live by the researcher in the participant's room. Room temperature and lighting will be adjusted according to the participant's preferences, and the ukulele sound level will be maintained between 70 and 73 dB throughout the intervention. Following the intervention, participants will complete assessments of pain catastrophizing, postpartum-specific anxiety, and postpartum comfort. |
| Routine Care Group | No intervention | –Participants assigned to this arm will receive the routine care and treatment provided by the clinical unit throughout the postoperative period, with no additional intervention during the study assessment period. The same outcome assessments will be administered at 25-26 hours after cesarean delivery. After completion of data collection, participants in the control group will be offered the same ukulele melody for 30 minutes as an ethical consideration. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparous women who have undergone cesarean delivery under spinal anesthesia
- No chronic disease
- Turkish-speaking
- Able to communicate effectively
- Willing to participate voluntarily and provide written informed consent
Key exclusion criteria (4 listed)
- Hearing impairment
- Cesarean delivery performed under epidural or general anesthesia
- Development of postoperative complications
- Requirement for additional analgesics beyond routine postoperative treatment
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 |
|---|---|---|
| Live Ukulele MusicWomen who were admitted to the postoperative unit and met the eligibility criteria were assessed by the researcher. Eligible women were provided with written and verbal information about the purpose of the study, the intervention procedures, ethical and institutional permissions, and the confidentiality of personal information. Written informed consent was obtained from women who agreed to participate in the study. Participants were assigned to the intervention and control groups in a 1:1 ratio using a computer-generated randomization sequence created with the RANDOM.ORG Sequence Generator (RANDOM.ORG, 2026). After the Informed Consent Form and Introductory Characteristics Questionnaire were administered to women assigned to the intervention group, the same standardized melody was performed live on the ukulele by the researcher for 30 minutes at 24 hours postoperatively. Following the intervention, the Postpartum Specific Anxiety Scale, Postpartum Comfort Scale, and Pain Catastrophizin | Behavioural | Live Ukulele Music Group |
Primary outcome
Pain Catastrophizing Level
Time frame: Between 25 and 26 hours postoperatively
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item self-report instrument assessing rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating higher levels of pain catastrophizing. The outcome will be compared between the ukulele music intervention group and the routine care control group.
Postpartum-Specific Anxiety Level
Time frame: Between 25 and 26 hours postoperatively
Postpartum-specific anxiety will be assessed using the Turkish version of the Postpartum Specific Anxiety Scale (PSAS). The scale consists of 47 items rated on a 4-point Likert scale, with higher total scores indicating higher levels of postpartum-specific anxiety. The outcome will be compared between the ukulele music intervention group and the routine care control group.
Postpartum Comfort Level
Time frame: Between 25 and 26 hours postoperatively
Postpartum comfort will be assessed using the Postpartum Comfort Questionnaire (PPCQ), a 34-item instrument evaluating physical, psychospiritual, and sociocultural comfort. Total scores range from 34 to 170, with higher scores indicating higher levels of postpartum comfort. The outcome will be compared between the ukulele music intervention group and the routine care control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Ukulele Music in people with Postpartum, run by Selcuk University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Catastrophizing Level (time frame: Between 25 and 26 hours postoperatively). 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 26 Aug 2026.