CClinicalTrials.gg
Not yet recruitingNCT07728266Updated Jul 27, 2026

Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision

An interventional study of Therapeutic Touch and Music intervention in Circumcision, sponsored by Igdir University. Not yet recruiting. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Igdir University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Circumcision

Keywords

  • Circumcision
  • Therapeutic Touch
  • Music Therapy
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In context

Lead sponsor

Igdir University is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Experimental: Therapeutic Touch Group

    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.

    Behavioral: Therapeutic Touch

  • Experimental
    Experimental: Music Group

    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.

    Behavioral: Music intervention

  • No intervention
    No Intervention: Control Group

    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.

Interventions

  • BehavioralTherapeutic Touch

    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.

  • BehavioralMusic intervention

    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.

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What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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

  3. 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.

    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.

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07728266
Lead sponsor
Igdir University
Responsible party
özlem ABI (lecturer, Igdir University) — Principal investigator
First posted
Jul 27, 2026
Start date
Dec 15, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Mar 12, 2027 (estimated)
Last update
Jul 27, 2026

Study contacts

Özlem abı
Contact
ozlemabi89@gmail.com
+905538840573

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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