Long-term Effect of Hypnosis in Spinal Cord Injury Patients
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|ClinicalTrials.gov Identifier: NCT03063333|
Recruitment Status : Not yet recruiting
First Posted : February 24, 2017
Last Update Posted : May 18, 2017
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.
|Condition or disease||Intervention/treatment|
|Spinal Cord Injuries||Other: Coping-oriented hypnosis Other: Neutral hypnosis|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Long-term Effect of Hypnosis in Spinal Cord Injury Patients|
|Anticipated Study Start Date :||May 18, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|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|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063333
|Contact: Lone Knudsen, PhDfirstname.lastname@example.org|
|Study Chair:||Helge Kasch, MD, PhD||Spinal Cord Injury Centre of Western Denmark|