About this trial

The proposed study aims to evaluate the effectiveness of hypnotherapy as a non-pharmacological intervention for managing pain and anxiety during needle-related medical procedures in children aged 5 to 17 years. This research addresses a significant gap in pediatric healthcare, where painful procedures often induce distress and long-term anxiety, leading to avoidance of necessary medical care. Conventional pain management strategies primarily rely on pharmacological methods, which may pose risks and side effects. Thus, exploring safe and effective alternatives, such as hypnotherapy, is crucial.The target group for this randomized controlled trial includes children scheduled for painful procedures, such as injections or blood sampling. Participants will be randomly assigned to either the hypnotherapy group, receiving tailored sessions conducted by trained hypnotherapists, or the standard of care group, which will involve conventional pain management techniques. The study will assess primary outcomes, including anxiety levels and pain perception, before, during, and after the procedures using validated scales.

Key activities of the project include conducting individualized hypnotherapy sessions, monitoring anxiety and pain levels through structured assessments, and analyzing the data to determine the effectiveness and feasibility of hypnotherapy. Secondary objectives will explore potential long-term benefits and safety concerns associated with hypnotherapy. If successful, this study could significantly enhance pediatric pain management practices, reduce reliance on pharmacological interventions, and improve the overall healthcare experience for children. The findings may also inform broader healthcare policies regarding non-pharmacological pain management strategies in pediatric settings.

Eligibility criteria

Qualifiers

Children aged 6 to 18 years

Scheduled for a painful medical procedure (injections or blood sampling)

Informed consent obtained from parents or legal guardians

Disqualifiers

Children with a history of psychiatric disorders or cognitive impairment

Children unable to understand and participate in hypnotherapy sessions

Any contraindication to hypnotherapy

Children with diagnosed cancer

Trial design

Treatments tested in this trial

  • Hypnotherapy

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

1
Aarhus University Hospital Aarhus Denmark

Sponsors and collaborators

Aarhus University Hospital

Lead sponsor