PainNCT07342751
The Effect of Listening to Music During Mobilization on Pain and Fear in Children Undergoing Abdominal Surgery
A study testing music in people with Pain and Surgery, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
This research is designed to improve the mobilization process in children aged 4-6 years undergoing abdominal surgery. The main objective of the study is to determine the effect of music listening on pain and fear levels in children who are standing up for the first time after surgery using a randomized controlled… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Pain, Surgery, Children, Only
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2026to 24 Jul 2026
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 4-6 years old
- Having undergone abdominal surgery
- Having undergone surgery under general anesthesia
- Having received a single dose of analgesic (paracetamol) after surgery
- Having undergone initial mobilization after surgery
- Being a volunteer to participate in the study
Who cannot join
- Having undergone previous surgery
- Having a chronic illness
- A parent having undergone abdominal surgery
- The child having visual, hearing, physical, or intellectual disabilities
Trial locations and contacts
1 site in 1 country.
About this study
This research is designed to improve the mobilization process in children aged 4-6 years undergoing abdominal surgery. The main objective of the study is to determine the effect of music listening on pain and fear levels in children who are standing up for the first time after surgery using a randomized controlled experimental method. This study, to be conducted at the Pediatric Surgery Department of Aksaray Training and Research Hospital, will involve a total of 74 children (37 in the study group and 37 in the control group) between January 2026 and November 2026.
According to the research protocol, children in the study group will listen to music of their own choosing during mobilization, while children in the control group will receive routine parental support from the clinic. During the data collection process, children's pain levels will be recorded using the Wong-Baker Pain Scale, and their fear levels using the Child Fear Scale, along with assessments from the child, parent, and nurse. Vital signs such as heart rate and respiratory rate will also be monitored before and after the procedure. This study aims to facilitate early mobilization in children and provide evidence as an effective non-pharmacological method in nursing care.
Read the detailed description
This randomized controlled experimental study aims to investigate the impact of music intervention on the pain and fear levels of children during the postoperative mobilization. Mobilization is a critical part of recovery, but it is often delayed in pediatric patients due to factors such as age, anxiety, fear, and pain. The study is designed to provide evidence for nurses on the use of non-pharmacological methods to facilitate early mobilization and improve the quality of surgical care.The research will be conducted at the Aksaray Training and Research Hospital Pediatric Surgery Department between January 2026 and November 2026. The study population consists of 74 children aged 4-6 who have undergone abdominal surgery. Participants will be randomly and equally divided into two groups: a study group (n=37) and a control group (n=37) using a computer-generated randomization program. Inclusion criteria require that the children be undergoing their first postoperative mobilization, have received only a single dose of paracetamol, and have no chronic illnesses or sensory impairments.The methodology involves assessing both groups before and after the mobilization process. Prior to mobilization, the baseline vital signs (heart rate, respiration, etc.) and pain and fear levels of all children will be evaluated by the child, their parents, and a nurse. During the mobilization, the study group will listen to music of their own choice through headphones, while the control group will receive standard clinical care with parental support. Immediately after the child returns to bed, the evaluations and vital sign recordings will be repeated to measure the intervention's effect.To ensure rigorous data collection, the researchers will use the Wong-Baker FACES Pain Rating Scale, the Children's Fear Scale (CFS), and a Vital Signs Tracking Form. Statistical analysis will be performed using SPSS 25.0, utilizing tests such as independent t-tests, Mann-Whitney U, and Chi-square to determine the significance of the results (p < .05). The study anticipates that the music intervention will significantly lower pain and fear scores, supporting the hypothesis that music is an effective supportive tool in pediatric surgical nursing.
- Conditions
- Pain, Surgery, Children, Only
- Being tested
- music
- Keywords
- pain, mobilisation, surgery, children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
Children in this group will be introduced to music of their choice and preference immediately before the mobilization begins.
| Study group | Role | What they receive |
|---|---|---|
| music | Experimental | Children in this group will be played their preferred and favorite music immediately before the mobilization process begins. The music will continue uninterrupted throughout the mobilization process and will end when the child returns to their bed after mobilization. Receives: Other: music |
| control | No intervention | Children in this group will not receive any musical entertainment; instead, mobilization will be carried out in accordance with the clinic's existing routine procedures, with parental support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Wong-Baker Scale
The Wong-Baker Scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983 to assess children's pain levels. It features six facial expressions scored from zero to five. The Wong-Baker Scale includes faces representing increasing pain intensity from zero to five, from left to right.
Measured: 1 day
Fear Scale
Developed by McMurtry et al. in 2011, it is a scale used to determine the anxiety/fear levels of children. The scale uses five picture faces. Fear level is evaluated with numbers between '0' and '4'. The first picture represents a score of '0', meaning 'no fear felt', and the fifth picture represents a score of '4', meaning 'severe fear'. As the score increases, the level of fear also increases (McMurtry et al., 2011; 780-788; Gerçeker et al., 2018:9-13). The translation and reliability study of the Child Fear Scale into Turkish was carried out by Özalp Gerçeker and colleagues in 2017.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start6 Jan 2026
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342751
- Sponsor's protocol ID
- 22102025
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christiaens, G. (2003). Independent nursing interventions for pain management. Home health care management &practice, 15(3), 212-214.
Cote, C. J., & Wilson, S. (2016). Guidelinesformonitoringandmanagement of pediatricpatientsbefore, during, andaftersedationfordiagnosticandtherapeuticprocedures: update 2016. PediatricDentistry, 38(4), E19-E39.
Gerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk anksiyete skalası-durumluluk ve çocuk korku ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13
Jones RA, Merkle S, Ruvalcaba L, Ashton P, Bailey C, Lopez M. Nurse-Led Mobility Program: Driving a Culture of Early Mobilization in Medical-Surgical Nursing. J Nurs Care Qual. 2020 Jan/Mar;35(1):20-26. doi: 10.1097/NCQ.0000000000000404.
PubMed 30889084Gıynaş, T., Önel, A. E., Küçük, S., Uğur, S., & Yardımcı, F. An Investigation of Using Non-PharmacologicalMethods in Pain Management in PostoperativePeriod in Children: A SystematicReview. Bilecik Şeyh Edebali Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 2(3), 172-190.
Sayar, S., & Ergin, D. (2019). Ortopedi servisinde yatan çocuk hastalarda ameliyat sonrası ağrı yönetiminde müziğin etkisinin incelenmesi. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 12(1), 67-73.
Kwekkeboom KL, Gretarsdottir E. Systematic review of relaxation interventions for pain. J Nurs Scholarsh. 2006;38(3):269-77. doi: 10.1111/j.1547-5069.2006.00113.x.
PubMed 17044345
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music During Mobilization on Pain and Fear in Children Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07342751
- Acronym / sponsor ID
- 22102025
- Conditions
- Pain, Surgery, Children, Only
- Keywords
- pain, mobilisation, surgery, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 15 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.
This research is designed to improve the mobilization process in children aged 4-6 years undergoing abdominal surgery. The main objective of the study is to determine the effect of music listening on pain and fear levels in children who are standing up for the first time after surgery using a randomized controlled experimental method. This study, to be conducted at the Pediatric Surgery Department of Aksaray Training and Research Hospital, will involve a total of 74 children (37 in the study group and 37 in the control group) between January 2026 and November 2026.
According to the research protocol, children in the study group will listen to music of their own choosing during mobilization, while children in the control group will receive routine parental support from the clinic. During the data collection process, children's pain levels will be recorded using the Wong-Baker Pain Scale, and their fear levels using the Child Fear Scale, along with assessments from the child, parent, and nurse. Vital signs such as heart rate and respiratory rate will also be monitored before and after the procedure. This study aims to facilitate early mobilization in children and provide evidence as an effective non-pharmacological method in nursing care.
Detailed description
This randomized controlled experimental study aims to investigate the impact of music intervention on the pain and fear levels of children during the postoperative mobilization. Mobilization is a critical part of recovery, but it is often delayed in pediatric patients due to factors such as age, anxiety, fear, and pain. The study is designed to provide evidence for nurses on the use of non-pharmacological methods to facilitate early mobilization and improve the quality of surgical care.The research will be conducted at the Aksaray Training and Research Hospital Pediatric Surgery Department between January 2026 and November 2026. The study population consists of 74 children aged 4-6 who have undergone abdominal surgery. Participants will be randomly and equally divided into two groups: a study group (n=37) and a control group (n=37) using a computer-generated randomization program. Inclusion criteria require that the children be undergoing their first postoperative mobilization, have received only a single dose of paracetamol, and have no chronic illnesses or sensory impairments.The methodology involves assessing both groups before and after the mobilization process. Prior to mobilization, the baseline vital signs (heart rate, respiration, etc.) and pain and fear levels of all children will be evaluated by the child, their parents, and a nurse. During the mobilization, the study group will listen to music of their own choice through headphones, while the control group will receive standard clinical care with parental support. Immediately after the child returns to bed, the evaluations and vital sign recordings will be repeated to measure the intervention's effect.To ensure rigorous data collection, the researchers will use the Wong-Baker FACES Pain Rating Scale, the Children's Fear Scale (CFS), and a Vital Signs Tracking Form. Statistical analysis will be performed using SPSS 25.0, utilizing tests such as independent t-tests, Mann-Whitney U, and Chi-square to determine the significance of the results (p < .05). The study anticipates that the music intervention will significantly lower pain and fear scores, supporting the hypothesis that music is an effective supportive tool in pediatric surgical nursing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Experimental | Other: musicChildren in this group will be played their preferred and favorite music immediately before the mobilization process begins. The music will continue uninterrupted throughout the mobilization process and will end when the child returns to their bed after mobilization. |
| control | No intervention | –Children in this group will not receive any musical entertainment; instead, mobilization will be carried out in accordance with the clinic's existing routine procedures, with parental support. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being between 4-6 years old
- Having undergone abdominal surgery
- Having undergone surgery under general anesthesia
- Having received a single dose of analgesic (paracetamol) after surgery
- Having undergone initial mobilization after surgery
Key exclusion criteria (4 listed)
- Having undergone previous surgery
- Having a chronic illness
- A parent having undergone abdominal surgery
- The child having visual, hearing, physical, or intellectual disabilities
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 |
|---|---|---|
| musicChildren in this group will be introduced to music of their choice and preference immediately before the mobilization begins. | Other | music |
Primary outcome
The Wong-Baker Scale
Time frame: 1 day
The Wong-Baker Scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983 to assess children's pain levels. It features six facial expressions scored from zero to five. The Wong-Baker Scale includes faces representing increasing pain intensity from zero to five, from left to right.
Fear Scale
Time frame: 1 day
Developed by McMurtry et al. in 2011, it is a scale used to determine the anxiety/fear levels of children. The scale uses five picture faces. Fear level is evaluated with numbers between '0' and '4'. The first picture represents a score of '0', meaning 'no fear felt', and the fifth picture represents a score of '4', meaning 'severe fear'. As the score increases, the level of fear also increases (McMurtry et al., 2011; 780-788; Gerçeker et al., 2018:9-13). The translation and reliability study of the Child Fear Scale into Turkish was carried out by Özalp Gerçeker and colleagues in 2017.
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 3 Aug 2026.
- BackgroundChristiaens, G. (2003). Independent nursing interventions for pain management. Home health care management &practice, 15(3), 212-214.
- BackgroundCote, C. J., & Wilson, S. (2016). Guidelinesformonitoringandmanagement of pediatricpatientsbefore, during, andaftersedationfordiagnosticandtherapeuticprocedures: update 2016. PediatricDentistry, 38(4), E19-E39.
- BackgroundGerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk anksiyete skalası-durumluluk ve çocuk korku ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13
- Background: PubMed 30889084Jones RA, Merkle S, Ruvalcaba L, Ashton P, Bailey C, Lopez M. Nurse-Led Mobility Program: Driving a Culture of Early Mobilization in Medical-Surgical Nursing. J Nurs Care Qual. 2020 Jan/Mar;35(1):20-26. doi: 10.1097/NCQ.0000000000000404.
- BackgroundGıynaş, T., Önel, A. E., Küçük, S., Uğur, S., & Yardımcı, F. An Investigation of Using Non-PharmacologicalMethods in Pain Management in PostoperativePeriod in Children: A SystematicReview. Bilecik Şeyh Edebali Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 2(3), 172-190.
- BackgroundSayar, S., & Ergin, D. (2019). Ortopedi servisinde yatan çocuk hastalarda ameliyat sonrası ağrı yönetiminde müziğin etkisinin incelenmesi. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 12(1), 67-73.
- Background: PubMed 17044345Kwekkeboom KL, Gretarsdottir E. Systematic review of relaxation interventions for pain. J Nurs Scholarsh. 2006;38(3):269-77. doi: 10.1111/j.1547-5069.2006.00113.x.
- 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 music in people with Pain and Surgery, run by Tarsus 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 6 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 3 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?
The Wong-Baker Scale (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342751, which also lists 7 linked publications.
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 3 Aug 2026.