Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypnotherapy.
- Who it may be relevant to
- Registry conditions: Arthritis, Juvenile, Arthritis, Juvenile Idiopathic, Lupus Erythematosus, Systemic, Dermatomyositis, Juvenile. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled Trial
Overview
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.
Interventions
- Other Hypnotherapy
The hypnotherapy session will be individualized to the particular child. The nurse performing the hypnotherapy session will ask the child a few basic questions about his/her favorite place or activity. If the child do not have any suggestions the nurse will suggest an age-appropriate activity to daydream about, such as making a snowman for a six year-old or skiing for an adolescent, and then suggest a hypnotic "daydream" about that place or activity. Most inductions for older children (ages appr
Primary outcome measures
- Level of anxiety before, during and after the medical procedure and pain intensity before, during and after the medical procedure. [Time frame: pre-procedure, periprocedurally and immediately after the procedure]
Secondary outcome measures (4)
- Generalized anxiety. [Time frame: Immediately after the procedure]
- Adverse events related to hypnotherapy [Time frame: Immediately after the procedure]
- The time spend on the total procedure [Time frame: from start to end of procedure]
- Heartrate [Time frame: pre-procedure, periprocedurally and immediately after the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT07349667 · 0097327