Adolescent Idiopathic Scoliosis (AIS)HYP-SCOLNCT07854951
Hypnosis for Pain and Nausea Reduction in Scoliosis Surgery: An Interventional Study
A study testing Hypnosis in people with Adolescent Idiopathic Scoliosis (AIS), run by St. Olavs Hospital at 1 site in Norway.
Trial summary
This study evaluates whether preoperative hypnosis can reduce postoperative pain, nausea, and opioid use in adolescents undergoing scoliosis surgery. Participants aged 12-18 years will receive hypnosis training before surgery. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 25 Nov 2025to 30 Dec 2026
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 12-18 years undergoing elective scoliosis surgery
- Provided informed consent for participation and data registration in the regional spine surgery registry
Who cannot join
- Severe cognitive impairment
- Language barriers preventing understanding of hypnosis instructions
- Lack of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs Hospital
Trondheim, 7006
Marit Johanne Resell Study Coordinator, Master, 41619946, marit.johanne.resell@gmail.com
Siri Winther
About this study
Official title: Effect of Preoperative Hypnosis on Postoperative Pain, Nausea, and Opioid Use in Adolescents Undergoing Scoliosis Surgery: A Quasi-Experimental Study With Historical Controls
This study evaluates whether preoperative hypnosis can reduce postoperative pain, nausea, and opioid use in adolescents undergoing scoliosis surgery. Participants aged 12-18 years will receive hypnosis training before surgery. Outcomes include pain scores, nausea severity, opioid consumption, and length of hospital stay. Results will be compared to a historical control group without hypnosis.
Read the detailed description
Scoliosis surgery is associated with significant postoperative pain and nausea, often requiring opioid analgesics, which can cause adverse effects. Non-pharmacological interventions such as hypnosis have shown promise in reducing pain and anxiety in surgical patients. This quasi-experimental study with historical controls aims to assess the effect of preoperative hypnosis on postoperative outcomes in adolescents undergoing elective scoliosis surgery at St. Olavs Hospital. The intervention group will receive hypnosis training prior to surgery, while the control group consists of patients operated in 2024 without hypnosis. Data will be collected from the hospital's internal spine surgery registry and include pain scores (numeric rating scale), nausea severity, opioid consumption, mobilization time, and length of stay. Statistical analyses will compare outcomes between groups using t-tests, Mann-Whitney U tests, and chi-square tests, with significance set at p<0.05. The study is approved by the Regional Committee for Medical and Health Research Ethics (REK Midt).
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Hypnosis
- Keywords
- Hypnosis, Pain Management, Postoperativ Pain, Nausea, Opioid Reduction, Spinal Surgery, Adolescents, Non-Pharmacological Intervention
- Medical subject headings
- Agnosia, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Participants receive preoperative hypnosis training delivered by certified psychologists. The intervention includes guided sessions and instruction in self-hypnosis techniques to reduce anxiety, pain, and nausea before and after scoliosis surgery.
| Study group | Role | What they receive |
|---|---|---|
| Interventions group | Experimental | Participants receive preoperative hypnosis training before scoliosis surgery. Receives: Behavioral: Hypnosis |
| Standard care | No intervention | Patients who underwent scoliosis surgery in 2024 without hypnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during rest and mobilization (Numeric Rating Scale 0-10)
Average pain score measured daily from postoperative day 0 to day 7 using a numeric rating scale (0 = no pain, 10 = worst pain).
Measured: Assessed daily from postoperative day 0 through postoperative day 7
Secondary outcomes (4)
Nausea severity
Measured daily using a 0-3 scale (0 = no nausea, 3 = severe nausea)
Measured: Assessed daily from postoperative day 0 through postoperative day 7
Total opioid consumption
Daily dose of Oxynorm (mg) recorded during hospitalization
Measured: Assessed daily from postoperative day 0 through postoperative day 7
Length of hospital stay
Number of days from surgery to discharge
Measured: Assessed daily from postoperative day 0 through postoperative day 7
Hours of mobilization per day
Total hours mobilized per day categorized as <1 hour, 1-5 hours, or >5 hours
Measured: Assessed daily from postoperative day 0 through postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start25 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by St. Olavs 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental design with historical control group. Two arms: intervention group receiving preoperative hypnosis and historical control group without hypnosis.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854951
- Sponsor's protocol ID
- 932123
- Acronym
- HYP-SCOL
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study uses data from an internal hospital registry and includes sensitive health information. Data sharing is restricted by Norwegian privacy regulations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Hypnosis on Postoperative Pain, Nausea, and Opioid Use in Adolescents Undergoing Scoliosis Surgery: A Quasi-Experimental Study With Historical Controls
- ClinicalTrials.gov ID
- NCT07854951
- Acronym / sponsor ID
- HYP-SCOL / 932123
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Hypnosis, Pain Management, Postoperativ Pain, Nausea, Opioid Reduction, Spinal Surgery, Adolescents, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- National Taiwan Normal University
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Oct 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.
This study evaluates whether preoperative hypnosis can reduce postoperative pain, nausea, and opioid use in adolescents undergoing scoliosis surgery. Participants aged 12-18 years will receive hypnosis training before surgery. Outcomes include pain scores, nausea severity, opioid consumption, and length of hospital stay. Results will be compared to a historical control group without hypnosis.
Detailed description
Scoliosis surgery is associated with significant postoperative pain and nausea, often requiring opioid analgesics, which can cause adverse effects. Non-pharmacological interventions such as hypnosis have shown promise in reducing pain and anxiety in surgical patients. This quasi-experimental study with historical controls aims to assess the effect of preoperative hypnosis on postoperative outcomes in adolescents undergoing elective scoliosis surgery at St. Olavs Hospital. The intervention group will receive hypnosis training prior to surgery, while the control group consists of patients operated in 2024 without hypnosis. Data will be collected from the hospital's internal spine surgery registry and include pain scores (numeric rating scale), nausea severity, opioid consumption, mobilization time, and length of stay. Statistical analyses will compare outcomes between groups using t-tests, Mann-Whitney U tests, and chi-square tests, with significance set at p<0.05. The study is approved by the Regional Committee for Medical and Health Research Ethics (REK Midt).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental design with historical control group. Two arms: intervention group receiving preoperative hypnosis and historical control group without hypnosis.
| Arm | Type | Receives |
|---|---|---|
| Interventions group | Experimental | Behavioral: HypnosisParticipants receive preoperative hypnosis training before scoliosis surgery. |
| Standard care | No intervention | –Patients who underwent scoliosis surgery in 2024 without hypnosis. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents aged 12-18 years undergoing elective scoliosis surgery
- Provided informed consent for participation and data registration in the regional spine surgery registry
Key exclusion criteria (3 listed)
- Severe cognitive impairment
- Language barriers preventing understanding of hypnosis instructions
- Lack of informed consent
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 |
|---|---|---|
| HypnosisParticipants receive preoperative hypnosis training delivered by certified psychologists. The intervention includes guided sessions and instruction in self-hypnosis techniques to reduce anxiety, pain, and nausea before and after scoliosis surgery. | Behavioural | Interventions group |
Primary outcome
Pain intensity during rest and mobilization (Numeric Rating Scale 0-10)
Time frame: Assessed daily from postoperative day 0 through postoperative day 7
Average pain score measured daily from postoperative day 0 to day 7 using a numeric rating scale (0 = no pain, 10 = worst pain).
4 secondary outcomes
Nausea severity
Time frame: Assessed daily from postoperative day 0 through postoperative day 7
Total opioid consumption
Time frame: Assessed daily from postoperative day 0 through postoperative day 7
Length of hospital stay
Time frame: Assessed daily from postoperative day 0 through postoperative day 7
Hours of mobilization per day
Time frame: Assessed daily from postoperative day 0 through postoperative day 7
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 2 Oct 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study uses data from an internal hospital registry and includes sensitive health information. Data sharing is restricted by Norwegian privacy regulations and institutional policies.
Related trials for Adolescent Idiopathic Scoliosis (AIS)
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
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 Hypnosis in people with Adolescent Idiopathic Scoliosis (AIS), run by St. Olavs Hospital at 1 site in Norway.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Norway. 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 Siri Winther Principal investigator, PHD (+4772573669, Siri.Bjorgen.Winther@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during rest and mobilization (Numeric Rating Scale 0-10) (time frame: Assessed daily from postoperative day 0 through postoperative day 7). 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 2 Oct 2026.