Comparing the effectiveness of hypnotherapy and behavioural therapy on sexual function, catastrophizing pain and fear of sexual intercourse in women diagnosed with Genito-Pelvic Pain/Penetration Disorder
The purpose of this study is to compare the effectiveness of behavioral therapy and hypnotherapy on sexual function, catastrophizing pain and fear of sexual intercourse in women with Genito-Pelvic Pain/Penetration Disorder
Design
Clinical trial with follow-up and control group, with parallel groups, not blind, randomized،including 45 women with GPPPD divided into three groups of 15 people
Settings and conduct
This study take place in Dr.Mokhtary' office.Treatment is performed individually.There are three questionnairs that they have to fill out in the begining,the end and a two- month fallow up.
Participants/Inclusion and exclusion criteria
Diagnosis of GPPPD, married, age between 15 to 35 years; ability to read and write, not having physical abnormality related to diagnosis, not having severe marital problem; absent for more than two sessions, not fill out the forms; and hypnotic susceptibility less than two for hypnotherapy group.
Intervention groups
hypnotherapy and behavioral therapy
Main outcome variables
sexual function
catastrophizing pain
fear of sexual intercourse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190204042619N1
Registration date:2019-07-19, 1398/04/28
Registration timing:registered_while_recruiting
Last update:2019-07-19, 1398/04/28
Update count:0
Registration date
2019-07-19, 1398/04/28
Registrant information
Name
Farzaneh Baktriya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2284 6510
Email address
fbaktriya@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of hypnotherapy and behavioural therapy on sexual function, catastrophizing pain and fear of sexual intercourse in women diagnosed with Genito-Pelvic Pain/Penetration Disorder
Public title
Behavioral therapy versus Hypnotherapy in women diagnosed with Vaginismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of GPPPD by a gynecologist.
Ability to write and read.
Not having related physical diseases
Not having severe marital problem
Not having severe psychological disorders
The Stanford hypnotic susceptibility should be at least in the medium range.
Exclusion criteria:
Hypnotic susceptibility less than two
Not fill out the questionnaires
Be absent more than two sessions
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Using the purposeful sampling, forty-five people are randomly assigned to three 15-member groups by minimization method. For this purpose the order of the groups is randomly determined and the first participant is allocated to a treatment group considering the produced order and the next participants enter the next groups respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences.Basij Blvd.Semnan.Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.SEMUMS.REC.1398.053
Health conditions studied
1
Description of health condition studied
Genito-Pelvic Pain/Penetration Disorder
ICD-10 code
N94.2
ICD-10 code description
Vaginismus
Primary outcomes
1
Description
sexual function
Timepoint
Before intervention, after intercourse , and a two- month follow-up
Method of measurement
sexual function questionnaire
2
Description
catastrophizing pain
Timepoint
Before intervention, after intercourse , and a two-month follow-up