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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN15615614
Date of registration: 30/06/2015
Prospective Registration: No
Primary sponsor: University Hospital Geneva
Public title: Hypnosis can reduce pain in hospitalized older patients
Scientific title: Hypnosis can reduce pain in hospitalized older patients: a randomized controlled study
Date of first enrolment: 01/01/2010
Target sample size: 50
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN15615614
Study type:  Interventional
Study design:  Randomized controlled study (Treatment)  
Phase: 
Countries of recruitment
Switzerland
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Sophie    Pautex
Address:  les Platanes, Chemin du Petit-Bel-Air 2, Chêne-Bourg 1225 Chêne-Bourg Switzerland
Telephone: 0041.79.553.46.82
Email: sophie.pautex@hcuge.ch
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Potentially eligible patients were identified by the team in charge of the patient or by the pain and palliative care consultation team. Patients were included starting from the fifth day of hospitalization, after stabilization of their acute illnesses.
Inclusion criteria were:
1. Chronic pain for more than 3 months with impact on daily living activities.
2. Intensity of pain higher than 4 on a numerical pain rating scale (0-10) at inclusion despite adequate analgesia.
3. EStatus examination >25
4. Post-traumatic stress disease
5. Active skin disease with a contraindication for massage

Exclusion criteria: 1. Deafness
2. Patient in his last days of life
3. Psychosis
4. Delirium (according to DSM-IV)
5. Cognitive impairment


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Potentially eligible patients were identified by the team in charge of the patient or by the pain and palliative care consultation team.
Signs and Symptoms
Intervention(s)
A single center randomized controlled trial using a two arm design (hypnosis versus massage) to assess the immediate and prolonged effect of hypnosis on the management of chronic pain in elderly patients.

Hypnosis:
The session was designed as suggested by Jensen and Petterson as a “brief hypnosis treatment”. Three sessions of 30 minutes (once a week according to the general condition of the patient) were conducted by a physician trained in medical hypnosis. We opted for a short number of sessions, because of the patients’ length of hospitalization. Before the session it was explained to the patients that the intervention consists in teaching them specific skills to help provide pain relief. The session was divided in the classical phases of hypnosis including induction, deepening and post hypnotic suggestions. During induction, patients were asked to imagine themselves in a nice place and to make some suggestions (selected according to their personal history) for analgesia and comfort. We practiced deepening and post hypnotic suggestions to obtain an effect of the treatment on the long run and to encourage the practice of self-hypnosis. Post-hypnotic suggestions were given by the therapist during the session that allow anchor and influence in the therapeutic goal established with the patient's perception of pain, time, memory, anxiety. Self-hypnosis was taught to the patient, with the aim to give them some form of control over pain.

Massage:
Massage is a technique that provides relaxation and improves well-being which helps reduce the feeling of pain. Three sessions of 30 minutes (once a week according to the general condition of the patient) were conducted by a nurse with a certification in massage. Patient was comfortably installed in a quiet room. At each session the patient could choose the area of massage: back massage or hands and arms or legs and feet (possibly abdomen or face).
Primary Outcome(s)
The third question of the Brief Pain Inventory (BPI) (average pain) measured at inclusion (T0), week one (T1) and two (T2), at discharge (T3) and 12 weeks (T12) later
Secondary Outcome(s)
The second part (pain interference with daily activities; 7 items) of the BPI measured at inclusion, at T0, T1, T2 and T3[20]. The BPI measures interference of pain with daily activities over the last 24 hours (mood, walking ability, normal work [including household], relationships, sleep, and enjoyment of life).The items are rated on a 0 to 10 scale, where 0 = no interference and 10 = interference as bad you can imagine. Mean interference score was calculated
Secondary ID(s)
Protocole 10-232/Psy 10-029
Source(s) of Monetary Support
University Hospital Geneva (Switzerland)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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