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
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.
- 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.