Impact of Therapeutic Osteopathy-hypnosis on Cancer Patients.
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Rafael
About this trial
Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.
Combining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years,
Patient diagnosed with cancer (currently undergoing treatment or having completed oncological treatment),
Experiencing chronic pain (≥ 3 months),
Presenting a strong emotional component to the pain: K10 score between 20 and 29,
Disqualifiers
Patients with no emotional distress or with severe distress
Sensory (auditory, visual) or cognitive deficits likely to hinder the conduct of hypnosis sessions
Patient who has undergone hypnotherapy sessions within the last 3 months
Patient unable to provide consent
Trial design
Design model
Parallel
Treatments tested in this trial
Osteopathy
BehavioralAn osteopathy session includes a health history chat, physical assessment, hands-on treatment, and aftercare advice.
Hypnosis
BehavioralHypnosis sessions consisted in deep relaxation and focused concentration, delivered by practitioners trained in the therapy.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: OsteopathyOther 1 intervention
Group B: Osteopathy + HypnosisExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pain and quality of life
Change in pain and functional quality of life assessed between baseline (Day 0) and 6 weeks using the Brief Pain Inventory (BPI). • Calculation: The mean (average) of four items measuring pain in the last 24 hours or past week: worst pain, least pain, average pain, and current pain ("pain right now"). (Alternatively, a single item like "worst pain" can be evaluated on its own). • Scale Range: 0 to 10 (0 = "no pain", 10 = "pain as bad as you could imagine"). Cut-offs: 0 - 3: Mild pain, 4 - 6: Moderate pain, 7 - 10: Severe pain
Time frame
6 weeksSecondary outcomes
1
Emotional distress variation
Change in emotional distress assessed at baseline, 6 weeks, and 1 month using the K10 psychological distress questionnaire (Kessler). Questions: 10 items. Scale: Each item is rated on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). Total Score Range: 10 to 50 (calculated by summing all 10 responses). .Results 10 - 15 (Low / Well): Little to no psychological distress; likely within normal limits. 16 - 21 (Moderate Distress): Mild to moderate levels of emotional strain or symptoms. 22 - 29 (High Distress): High level of psychological distress; may indicate a mild-to-moderate mental health disorder requiring attention or early intervention; 30 - 50 (Very High / Severe Distress): Severe psychological distress; strongly indicates a probable serious mental health condition and a need for professional evaluation or specialist referral.
Time frame
6 weeks2
Patient's experience
Semi-structured qualitative questionnaire on the experience and perception of the combined treatment, administered one month after the final session
Time frame
1 month after final interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Rafael
Lead sponsor
Hartmann Oncology Radiotherapy Group, France
Collaborator
Source ClinicalTrials.gov