CircumcisionNCT07728266
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
A study testing Therapeutic Touch and Music intervention in people with Circumcision, run by Igdir University.
Trial summary
This randomized controlled trial aims to evaluate the effects of therapeutic touch and music therapy on anxiety, pain, and nausea in children undergoing circumcision surgery. Circumcision is a common surgical procedure, and children often experience significant anxiety, pain, and nausea both before and after the… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumcision
- What is being tested?
- Therapeutic Touch and Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 12 Mar 2027
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 7 and 12 years
- Children and parents who provide written and verbal informed consent
- Children without any chronic diseases
- Children and parents without visual impairments
Who cannot join
- Children and parents who refuse to participate or do not volunteer for the study (do not sign the consent form)
- Participants who display behaviors incompatible with the research content -Participants who subsequently refuse to participate in the research after initial consent
- Participants with incomplete data
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
Official title: Effects of Therapeutic Touch and Music on Anxiety, Pain, and Nausea in Children Before and After Circumcision: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of therapeutic touch and music therapy on anxiety, pain, and nausea in children undergoing circumcision surgery. Circumcision is a common surgical procedure, and children often experience significant anxiety, pain, and nausea both before and after the operation. The study involves children aged 7 to 12 years old who are scheduled for circumcision at Iğdır State Hospital. Participants will be randomly assigned to one of three groups: a therapeutic touch group, a music therapy group, or a control group. The goal of this research is to determine if applying non-pharmacological methods-specifically therapeutic touch or listening to music-for 15 minutes before and after the surgery can effectively reduce children's anxiety, pain levels, and nausea compared to standard care.
- Conditions
- Circumcision
- Being tested
- Therapeutic Touch, Music intervention
- Keywords
- Circumcision, Therapeutic Touch, Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
A certified researcher will apply therapeutic touch to the child for 15 minutes before the circumcision operation. Following the surgery (approximately 60 minutes later, once the effects of sedation have passed and the child is conscious), another 15-minute therapeutic touch session will be applied.
Music interventionBehavioural
The child will listen to music for 15 minutes before the circumcision operation. Following the surgery (approximately 60 minutes later, once the effects of sedation have passed and the child is conscious), the child will listen to music for an additional 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Therapeutic Touch Group | Experimental | Participants in this group will receive a 15-minute therapeutic touch intervention prior to the circumcision surgery. Post-operatively, 60 minutes after the operation when the effects of sedation have passed and the child has regained consciousness, they will receive another 15-minute therapeutic touch intervention. Receives: Behavioral: Therapeutic Touch |
| Experimental: Music Group | Experimental | Participants in this group will listen to music for 15 minutes before the circumcision surgery. Post-operatively, 60 minutes after the operation once sedation effects have worn off, they will listen to music for an additional 15 minutes. Receives: Behavioral: Music intervention |
| No Intervention: Control Group | No intervention | Participants in this group will receive only the standard routine hospital care for their procedure. No additional experimental interventions (neither therapeutic touch nor music) will be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be evaluated using the Wong-Baker FACES Pain Rating Scale. This assessment tool uses a scoring system ranging from 0 to 5, where 0 represents "no pain" and 5 represents "very severe pain," correlating with the patient's chosen facial expression.
Measured: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.
Nausea Severity
Nausea will be assessed using the Baxter Retching Faces (BARF) Nausea Scale. This pictorial scale consists of six faces and is scored from 0 to 10, where 0 indicates no nausea/vomiting and 10 indicates severe nausea/vomiting.
Measured: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op
Anxiety Level
The children's state anxiety will be measured using the Children's Anxiety Scale-State (CAS-S) / Çocuk Anksiyete Skalası-Durumluluk (ÇAS-D). This is a visual analog scale shaped like a thermometer with a bulb at the bottom and horizontal lines increasing upwards, specifically designed for children aged 4 to 12. Children are instructed to indicate their level of worry or tension by drawing a line on the thermometer. Before administering the scale, the child's ability to understand instructions and sequence numbers (such as counting to 10 or determining if 7 or 4 is larger) is evaluated; children who cannot complete these cognitive tasks do not complete the scale. The total score ranges from 0 to 10, with higher scores representing higher levels of anxiety.
Measured: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CircumcisionStudies 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 is designed as a randomized controlled trial where participants are concurrently assigned to one of three separate groups: a therapeutic touch group, a music group, and a standard care control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özlem ABI, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728266
- Sponsor's protocol ID
- OABI_IGDIR_02
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharara-Chami R, El-Hout Y, Lakissian Z, Hafez B, Abi-Gerges C, Fayad J, Charafeddine L, Tazian V, Tamim H, Zaghal A. Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial. J Pediatr Urol. 2022 Apr;18(2):184.e1-184.e6. doi: 10.1016/j.jpurol.2021.12.011. Epub 2021 Dec 24.
PubMed 35000838
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Touch and Music on Anxiety, Pain, and Nausea in Children Before and After Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07728266
- Acronym / sponsor ID
- OABI_IGDIR_02
- Conditions
- Circumcision
- Keywords
- Circumcision, Therapeutic Touch, Music Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 27 Jul 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 randomized controlled trial aims to evaluate the effects of therapeutic touch and music therapy on anxiety, pain, and nausea in children undergoing circumcision surgery. Circumcision is a common surgical procedure, and children often experience significant anxiety, pain, and nausea both before and after the operation. The study involves children aged 7 to 12 years old who are scheduled for circumcision at Iğdır State Hospital. Participants will be randomly assigned to one of three groups: a therapeutic touch group, a music therapy group, or a control group. The goal of this research is to determine if applying non-pharmacological methods-specifically therapeutic touch or listening to music-for 15 minutes before and after the surgery can effectively reduce children's anxiety, pain levels, and nausea compared to standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study is designed as a randomized controlled trial where participants are concurrently assigned to one of three separate groups: a therapeutic touch group, a music group, and a standard care control group
| Arm | Type | Receives |
|---|---|---|
| Experimental: Therapeutic Touch Group | Experimental | Behavioral: Therapeutic TouchParticipants in this group will receive a 15-minute therapeutic touch intervention prior to the circumcision surgery. Post-operatively, 60 minutes after the operation when the effects of sedation have passed and the child has regained consciousness, they will receive another 15-minute therapeutic touch intervention. |
| Experimental: Music Group | Experimental | Behavioral: Music interventionParticipants in this group will listen to music for 15 minutes before the circumcision surgery. Post-operatively, 60 minutes after the operation once sedation effects have worn off, they will listen to music for an additional 15 minutes. |
| No Intervention: Control Group | No intervention | –Participants in this group will receive only the standard routine hospital care for their procedure. No additional experimental interventions (neither therapeutic touch nor music) will be applied to this group. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged between 7 and 12 years
- Children and parents who provide written and verbal informed consent
- Children without any chronic diseases
- Children and parents without visual impairments
Key exclusion criteria (3 listed)
- Children and parents who refuse to participate or do not volunteer for the study (do not sign the consent form)
- Participants who display behaviors incompatible with the research content -Participants who subsequently refuse to participate in the research after initial consent
- Participants with incomplete data
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 |
|---|---|---|
| Therapeutic TouchA certified researcher will apply therapeutic touch to the child for 15 minutes before the circumcision operation. Following the surgery (approximately 60 minutes later, once the effects of sedation have passed and the child is conscious), another 15-minute therapeutic touch session will be applied. | Behavioural | Experimental: Therapeutic Touch Group |
| Music interventionThe child will listen to music for 15 minutes before the circumcision operation. Following the surgery (approximately 60 minutes later, once the effects of sedation have passed and the child is conscious), the child will listen to music for an additional 15 minutes. | Behavioural | Experimental: Music Group |
Primary outcome
Pain Intensity
Time frame: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.
Pain intensity will be evaluated using the Wong-Baker FACES Pain Rating Scale. This assessment tool uses a scoring system ranging from 0 to 5, where 0 represents "no pain" and 5 represents "very severe pain," correlating with the patient's chosen facial expression.
Nausea Severity
Time frame: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op
Nausea will be assessed using the Baxter Retching Faces (BARF) Nausea Scale. This pictorial scale consists of six faces and is scored from 0 to 10, where 0 indicates no nausea/vomiting and 10 indicates severe nausea/vomiting.
Anxiety Level
Time frame: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.
The children's state anxiety will be measured using the Children's Anxiety Scale-State (CAS-S) / Çocuk Anksiyete Skalası-Durumluluk (ÇAS-D). This is a visual analog scale shaped like a thermometer with a bulb at the bottom and horizontal lines increasing upwards, specifically designed for children aged 4 to 12. Children are instructed to indicate their level of worry or tension by drawing a line on the thermometer. Before administering the scale, the child's ability to understand instructions and sequence numbers (such as counting to 10 or determining if 7 or 4 is larger) is evaluated; children who cannot complete these cognitive tasks do not complete the scale. The total score ranges from 0 to 10, with higher scores representing higher levels of anxiety.
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 27 Jul 2026.
- Background: PubMed 35000838Sharara-Chami R, El-Hout Y, Lakissian Z, Hafez B, Abi-Gerges C, Fayad J, Charafeddine L, Tazian V, Tamim H, Zaghal A. Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial. J Pediatr Urol. 2022 Apr;18(2):184.e1-184.e6. doi: 10.1016/j.jpurol.2021.12.011. Epub 2021 Dec 24.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch and Music intervention in people with Circumcision, run by Igdir 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 4 inclusion and 3 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 27 Jul 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 Özlem abı (+905538840573, ozlemabi89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.). 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?
On the ClinicalTrials.gov record for NCT07728266, which also lists 1 linked publication.
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 27 Jul 2026.