Aim: This study conduct with the aim of effect of self-hypnosis on degree of pain in patients with multiple sclerosis.
Design: Double blind
Setting and conduct: The data collection tools were General health questionnaire-28 (GHQ-28), Stanford hypnotic susceptibility scale(SHSS), numerical rating scale, McGill pain questionnaire and record of pain pills. After initial assessments, patients were randomly assigned to two groups of intervention and control.
Participants: This study was carried out on 60 patients with MS in Urmia city.The most important inclusion criteria:
A definitive diagnosis of multiple sclerosis ; a member of MS society of Urmia; reported pain at least in one area of their body(pain score at least 4 of 10); Hypnotic susceptibility score higher than 24 on Stanford Hypnotic Susceptibility Scale; General Health Questionnaire score less than 23; The absence of any sign of psychosis, suicidal thoughts in the past 6 months, The most important exclusion criteria: Hospitalization in a hospital or exacerbation during the study.
Interventions: Education of Self-Hypnosis for the intervention group was performed within 6 half-hour sessions, with no intervention for control group.
Variables: pain intensity, pain quality
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021216564N1
Registration date:2015-07-13, 1394/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-13, 1394/04/22
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences and Health Servivce
Expected recruitment start date
2014-07-16, 1393/04/25
Expected recruitment end date
2014-08-16, 1393/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self hypnosis on pain in women with multiple sclerosis
Public title
Effect of self hypnosis on pain in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
The most important inclusion criteria:
A definitive diagnosis of multiple sclerosis was carried out by a specialist; a member of MS society of Urmia city; women aged between 18-50 years; to be literate;reported pain at least in one area of their body(pain score at least 4 of 10); willingness to participate in the study; Hypnotic susceptibility score higher than 24 on Stanford Hypnotic Susceptibility Scale; General Health Questionnaire score less than 23; The absence of any sign of psychosis, suicidal thoughts in the past 6 months, substance abuse, personality disorders, cognitive disorders, epilepsy is listed in the patient's medical documents.
The most important exclusion criteria: Hospitalization in a hospital or exacerbation during the study.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Urmia university of Medical Scinces
Street address
Urmia University of Medical Sciences and Health Serviceو, Next Emergency Center, Resalat Blvd
City
Urmia
Postal code
5714783734
Approval date
2014-07-15, 1393/04/24
Ethics committee reference number
umsu.rec1393.108
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
pain
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Severity of pain
Timepoint
Every day
Method of measurement
Numerical rating scale
2
Description
Quality of pain
Timepoint
Every day
Method of measurement
Mc gill
Secondary outcomes
empty
Intervention groups
1
Description
Self hypnosis was trained by researcher, approved by Iranian society of clinical hypnosis. patients in intervention group received 6 sessions, 30 minute each, with one week intervals. Induction of self hypnosis was started with progressive muscle relaxation and followed by appropriate suggestions (for pain control, relaxation and increasing self-esteem). Patients in the intervention group were asked to perform self-hypnosis at least 10 times or more each day.
Then change of pain severity and quality and amount of pain pills were evaluated after one month. all of patients receive their standard care as suggested by the attending neurologist.