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

ConditionCircumcision
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorIgdir University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Touch

    Behavioral

    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 intervention

    Behavioral

    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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Experimental: Therapeutic Touch GroupExperimental treatment 1 intervention
Group B: Experimental: Music GroupExperimental treatment 1 intervention
Group C: No Intervention: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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