Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting

Aarhus University Hospital

Status: Begins enrollment this month

Conditions: Lupus Erythematosus, Systemic; Arthritis, Juvenile Idiopathic; Arthritis, Juvenile; Dermatomyositis, Juvenile

Treatments: Other: Hypnotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07349667

0097327

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 6 to 18 years
• Scheduled for a painful medical procedure (injections or blood sampling)
• Informed consent obtained from parents or legal guardians

Exclusion criteria

• 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

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Hypnotherapy

Other group

Description:

Childrenin the intervention group will receive hypnotherapy sessions conducted by one of two trained and certified hypnotherapists. The sessions will be tailored to the child's age and understanding

Treatment:

Other: Hypnotherapy

Control group

No Intervention group

Description:

Children in the control group will receive standard care for pain management during medical procedures.