ClinicalTrials.gov record NCT07349667

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled Trial

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age6 years old to 18 years old
SexAll
LocationDenmark
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized trial compares individualized hypnotherapy with standard care for children having needle procedures (eg, injections or blood draws). It measures anxiety and pain before, during, and after the procedure and records safety and procedure-related outcomes. Participants are assigned to either hypnotherapy delivered by trained hypnotherapists or to usual pain-management care.

What it is studying. The study is testing whether a tailored hypnotherapy session given to children around the time of a needle procedure affects their anxiety and pain scores measured before, during, and immediately after the procedure. The study also collects measures of general anxiety, heart rate, time spent on the procedure, and any adverse effects reported after hypnotherapy.

What the researchers hope to learn. To determine if hypnotherapy changes anxiety or pain during needle procedures, to evaluate related safety signals, and to assess procedure time and feasibility in a pediatric setting.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Hypnotherapy

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

At the procedure visit the child will be randomly assigned to either a tailored hypnotherapy session led by a trained hypnotherapist or to standard care for the needle procedure. Study staff will assess anxiety and pain before, during, and immediately after the procedure using questionnaires, record heart rate, and measure the time spent on the procedure. Children will be asked about possible side effects such as nausea or dizziness immediately after the procedure. Participation activities are centered on the needle-related procedure visit and the brief assessments around it.

How the study is structured. Interventional, randomized, parallel-group trial with no masking. Children are randomly assigned to a hypnotherapy session delivered by trained staff or to standard care; outcomes are measured before, during, and immediately after the procedure.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Arthritis, Juvenile; Arthritis, Juvenile Idiopathic; Lupus Erythematosus, Systemic; Dermatomyositis, Juvenile. Does it apply to my diagnosis?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Denmark. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on polymyositis

This trial is also listed on this site under dermatomyositis.

Clinical trials55 trials listed for polymyositisEvery trial the registry lists for polymyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in polymyositis researchLatest monthly update: September 2026. Includes: CD4 count risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
March 2026 (estimated)
Primary completion
September 2029 (estimated)
Study completion
December 2029 (estimated)
Target enrollment
70 participants (estimated)
Last updated on registry
Jan 20, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Aarhus University Hospital
Principal investigator
Claus Sixtus Jensen, Associate professor
Aarhus University Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Aarhus University Hospital

    Aarhus · Denmark

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
Informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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