Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to reduce pain in people with chronic tension-type headache and experimental pain in healthy volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain post-hypnosis is unknown.
The aim is to investigate the durational effect of a single session of coping-oriented hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or may be used in conjunction with lower medicine dosages.
Methods: 75 patients with spinal cord injury and pain is randomized into one of three conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing, anxiety and depression is assessed before intervention and over a period of 14 days post-intervention.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosisMasking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Long-term Effect of Hypnosis in Spinal Cord Injury Patients|
- Pain intensity [ Time Frame: For 14 days post-intervention ]NRS (0-10)
- Coping [ Time Frame: For 14 days post-intervention ]Coping strategies questionnaire
- Pain catastrophizing [ Time Frame: For 14 days post-intervention ]Pain catastrophizing scale
- Pain impact on mood, sleep and daily activities [ Time Frame: For 14 days post-intervention ]NRS (0-10)
- Anxiety [ Time Frame: For 14 days post-intervention ]Hospital Anxiety and Depression Scale
- Depression [ Time Frame: For 14 days post-intervention ]Hospital Anxiety and Depression Scale
- Global impression of change [ Time Frame: For 14 days post-intervention ]Global impression of change scale
- Side effects [ Time Frame: For 14 days post-intervention ]patient report
|Anticipated Study Start Date:||May 18, 2017|
|Estimated Study Completion Date:||December 31, 2019|
|Estimated Primary Completion Date:||December 31, 2019 (Final data collection date for primary outcome measure)|
|Experimental: Coping-oriented hypnosis||
Other: Coping-oriented hypnosis
Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
|Placebo Comparator: Neutral hypnosis||
Other: Neutral hypnosis
Hypnosis using neutral suggestions plus current treatment
|No Intervention: current treatment only|
Please refer to this study by its ClinicalTrials.gov identifier: NCT03063333
|Contact: Lone Knudsen, PhDfirstname.lastname@example.org|
|Study Chair:||Helge Kasch, MD, PhD||Spinal Cord Injury Centre of Western Denmark|