NCT Number: NCT07728266
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.
Trial opening soon.
Get Notified7 year–12 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Igdir University
Other
Effects of Therapeutic Touch and Music on Anxiety, Pain, and Nausea in Children Before and After Circumcision: A Randomized Controlled Trial
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