Long-term Effect of Hypnosis in Spinal Cord Injury Patients

Not Applicable

Terminated

• Conditions: Spinal Cord Injuries
• Interventions: Other: Coping-oriented hypnosis; Other: Neutral hypnosis

• Registration Number: NCT03063333
• Lead Sponsor: Lone Knudsen, MSc Psych, PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-05-17
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning
• Baseline pain level of ≥ 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain)
• Pain duration of at least 8 weeks.

Exclusion Criteria

• Severe mental or psychiatric illness
• Substance abuse (drugs, alcohol or medicine)
• Lack of ability to cooperate during the experiment
• Severe high cervical lesions
• Severe autonomic dysautonomia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coping-oriented hypnosis	Coping-oriented hypnosis	-
Neutral hypnosis	Neutral hypnosis	-

Primary Outcome Measures

Name	Time	Method
Pain intensity	For 14 days post-intervention	NRS (0-10)
Coping	For 14 days post-intervention	Coping strategies questionnaire

Secondary Outcome Measures

Name	Time	Method
Pain catastrophizing	For 14 days post-intervention	Pain catastrophizing scale
Pain impact on mood, sleep and daily activities	For 14 days post-intervention	NRS (0-10)
Global impression of change	For 14 days post-intervention	Global impression of change scale
Anxiety	For 14 days post-intervention	Hospital Anxiety and Depression Scale
Depression	For 14 days post-intervention	Hospital Anxiety and Depression Scale

Trial Locations

Locations (1)

Spinal Cord Injury Centre of Western Denmark; 🇩🇰 Viborg, Denmark