Arthritis, JuvenileNCT07349667
Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting
A study testing Hypnotherapy in people with Arthritis, Juvenile and Arthritis, Juvenile Idiopathic, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Arthritis, Juvenile, Arthritis, Juvenile Idiopathic, Lupus Erythematosus, Systemic
- What is being tested?
- Hypnotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6 to 18 years
- Scheduled for a painful medical procedure (injections or blood sampling)
- Informed consent obtained from parents or legal guardians
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aarhus University Hospital
Aarhus
Claus S Jensen, PhD, +4527304696
About this study
Official title: Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled 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.
- Conditions
- Arthritis, Juvenile, Arthritis, Juvenile Idiopathic, Lupus Erythematosus, Systemic, Dermatomyositis, Juvenile
- Being tested
- Hypnotherapy
- Keywords
- Hypnotherapy, pediatric, needle fear
- Medical subject headings
- Arthritis, Juvenile, Lupus Erythematosus, Systemic, Dermatomyositis, Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnotherapyOther
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 approximately 9-15) included a few slow, deep breaths and/or some progressive relaxation, such as muscle relaxation or the suggestion of a "warm, comfortable feeling" flowing up the body from the feet to the head. Younger children, unless they expressed an interest in deep breathing or relaxation, will typically asked simply to imagine themselves arriving at their favorite place and/or beginning their favorite activity.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy | Other | 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 Receives: Other: Hypnotherapy |
| Control group | No intervention | Children in the control group will receive standard care for pain management during medical procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety before, during and after the medical procedure and pain intensity before, during and after the medical procedure.
Anxiety will be measure using Modified Yale Preoperative Anxiety Scale. The instrument contains 27 items in five categories indicating anxiety in children (activity, emotional expressivity, state of arousal, vocalization, and use of parents). Scores range from 22 to 100; higher scores indicate higher levels of anxiety.
Measured: pre-procedure, periprocedurally and immediately after the procedure
Secondary outcomes (4)
Generalized anxiety.
Spence Children's Anxiety Scale. The Spence Children's Anxiety Scale - Child Version (SCAS-Child) is a 44-item self-report measure, with responses recorded on a 4-point scale ranging from 0 (never) to 3 (always), designed to assess anxiety symptoms in children aged 8-15 years. Built upon contemporary diagnostic frameworks, the SCAS-Child evaluates six distinct domains of anxiety that align with clinical diagnostic categories. A higher score on the Spence Children's Anxiety Scale (SCAS) indicates a greater severity and number of anxiety symptoms, suggesting the child experiences more significant anxiety, which can be further broken down into subscales for specific fears like separation anxiety, social phobia, or panic.
Measured: Immediately after the procedure
Adverse events related to hypnotherapy
Adverse events related to hypnotherapy. Will be evaluated by asking patients to rate nausea and dizziness on a self-constructed 4-point scale (range 0-3; 0, no nausea/dizziness at all; 3, severely nauseous/dizzy).
Measured: Immediately after the procedure
The time spend on the total procedure
time spend on the intervention and the needle-related procedure.
Measured: from start to end of procedure
Heartrate
Heart rate
Measured: pre-procedure, periprocedurally and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, JuvenileStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Sixtus Jensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349667
- Sponsor's protocol ID
- 0097327
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) from this study cannot be shared. As a single-center study with a small cohort, participants could potentially be re-identified even after anonymization. Sharing the data would therefore risk exposing sensitive personal or health information.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349667
- Acronym / sponsor ID
- 0097327
- Conditions
- Arthritis, Juvenile, Arthritis, Juvenile Idiopathic, Lupus Erythematosus, Systemic, Dermatomyositis, Juvenile
- Keywords
- Hypnotherapy, pediatric, needle fear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Other | Other: HypnotherapyChildrenin 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 |
| Control group | No intervention | –Children in the control group will receive standard care for pain management during medical procedures. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 6 to 18 years
- Scheduled for a painful medical procedure (injections or blood sampling)
- Informed consent obtained from parents or legal guardians
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnotherapyThe 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 approximately 9-15) included a few slow, deep breaths and/or some progressive relaxation, such as muscle relaxation or the suggestion of a "warm, comfortable feeling" flowing up the body from the feet to the head. Younger children, unless they expressed an interest in deep breathing or relaxation, will typically asked simply to imagine themselves arriving at their favorite place and/or beginning their favorite activity. | Other | Hypnotherapy |
Primary outcome
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
Anxiety will be measure using Modified Yale Preoperative Anxiety Scale. The instrument contains 27 items in five categories indicating anxiety in children (activity, emotional expressivity, state of arousal, vocalization, and use of parents). Scores range from 22 to 100; higher scores indicate higher levels of anxiety.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) from this study cannot be shared. As a single-center study with a small cohort, participants could potentially be re-identified even after anonymization. Sharing the data would therefore risk exposing sensitive personal or health information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy in people with Arthritis, Juvenile and Arthritis, Juvenile Idiopathic, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claus S Jensen, PhD (+4527304696, claus.sixtus.jensen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.