This study is aimed to assess the effectiveness of hypnosis in symptom relief of premenstrual syndrome and comparison with muscle relaxation exercises. Study population are 30 females referred to the two hospitals affiliated to Babol University of Medical Sciences who have premenstrual syndrome according to premenstrual syndrome screening scale and not to have exclusion criteria in baseline psychiatric visit. These 30 patients will be allocated randomly in two case (intervention) and control groups. 15 patients in case group will be under a standardized course of hypnotherapy included 6 weekly sessions of hypnosis ( duration of each session: almost 30 minutes). In 15 patients of control group, six sessions of muscle relaxation exercises will be educated weekly. Hypnosis and muscle relaxation exercises will be carried out by a psychiatrist, faculty member, who has passed training course of hypnosis and has certificate of participation in this course. The status of the patients in both two groups will be evaluated in the first and third months after treatment with premenstrual symptoms screening and severity tool.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092822991N7
Registration date:2016-10-12, 1395/07/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-12, 1395/07/21
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Babol University of Medical Sciences
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of hypnosis and muscle relaxation exercises in symptom relief of premenstrual syndrome
Public title
Effectiveness of hypnosis in symptom relief of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having premenstrual syndrome criteria; signing informed consent form
Exclusion criteria: to have other organic diseases (based on the patient statement); serious psychiatric disorders ( in baseline psychiatric visit); continuous use of special drugs, contraceptives or alcohol, narcotics and psychotropic drugs; not filling out and signing informed consent form; previous experience of hypnosis; pregnancy or breast feeding
Age
From 10 years old to 60 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers table is used for randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
University of Medical Sciences, Babol
City
Babol
Postal code
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
Mubabol.Rec.1394.185
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
premenstrual symptoms
Timepoint
first and third months of treatment
Method of measurement
premenstrual symptoms screening tool
Secondary outcomes
1
Description
mental status of the patients
Timepoint
weekly
Method of measurement
psychiatric visit
Intervention groups
1
Description
Intervention group: a standardized course of hypnotherapy included 6 weekly sessions of hypnosis (duration of each session: almost 30 minutes)
Category
Treatment - Other
2
Description
Control group: six sessions of weekly muscle relaxation exercises