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Comparison of Relaxation Effectiveness by Hypnotherapy and Virtual Reality Technology on Depression, Anxiety and stress in Female Students with Premenstrual Syndrome

Protocol summary

Study aim
Comparison of Relaxation Effectiveness by Hypnotherapy and Virtual Reality Technology on Depression, Anxiety and stress in Female Students with Premenstrual Syndrome
Design
In this research , 90 female students with premenstrual syndrome who are eligible to enter the study are selected. Participants are randomly assigned to three intervention and control groups and each participant is assigned a code.
Settings and conduct
In this research, after obtaining the necessary permissions, using qualitative sampling, referring to the Kermanshah University of Medical Sciences dormitories, after obtaining informed consent, eligible samples are selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having an age range of 27-18 years; having regular menstruation (interval between two cycles of 35-22 days); having normal menstrual bleeding of 3 to 8 days; earning a score of 18 up from the screening tool for premenstrual syndrome (cases Moderate and severe). Exclusion criteria: history of drug use or cigarette, history of ovarian cysts or women's surgery, history of underlying diseases affecting premenstrual syndrome (including cardiovascular, respiratory, renal, hypertension, asthma, diabetes, epilepsy, migraine, thyroid , Anemia and psychiatric illnesses) having a history of mental illness and depression; history of taking antidepressants, sedation and hormones, adverse events or deaths of loved ones and divorce in the last three months.
Intervention groups
Intervention group 1: Relaxation with virtual reality Intervention group 2: Relaxation with hypnosis
Main outcome variables
anxiety, depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151208025433N4
Registration date: 2017-11-29, 1396/09/08
Registration timing: prospective

Last update: 2017-11-29, 1396/09/08
Update count: 0
Registration date
2017-11-29, 1396/09/08
Registrant information
Name
Fatemeh Dehghan
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 1439
Email address
srghasemi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Relaxation Effectiveness by Hypnotherapy and Virtual Reality Technology on Depression, Anxiety and stress in Female Students with Premenstrual Syndrome
Public title
Comparison of Relaxation Effectiveness by Hypnotherapy and Virtual Reality Technology on Depression, Anxiety and stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having ages 27-18 years Having regular menstruation (interval between two cycles of 35-22 days) Having normal menstrual bleeding 3 to 8 days Earning a score of 18 up by the screening tool for premenstrual syndrome (moderate and severe)
Exclusion criteria:
History of drug use or cigarette History of ovarian cyst or female surgeries History of underlying diseases affecting premenstrual syndrome (including cardiovascular, respiratory, renal, hypertension, asthma, diabetes, epilepsy, migraine, thyroid, anemia and diseases Nervous and psychological) Having a history of depression history of taking antidepressants sedation and hormones, adverse events or deaths of loved ones and divorce in the last three months
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation based on the lottery will be allocated to the control group and the intervention teams.
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 committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor of Research,No 2 Building , Kermanshah University of Medical Sciences,Martyr Shahid Beheshti, Kermanshahi
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.KUMS.REC.1396.390

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F39
ICD-10 code description
Unspecified mood [affective] disorder

Primary outcomes

1

Description
Depression
Timepoint
Before treatment
Method of measurement
DASS - 21 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Relaxation
Category
Behavior

2

Description
Intervention group: Hypnosis
Category
Behavior

3

Description
Control group: Failure to do extra work
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan
Street address
Vice President of Research, Building 2, Kermanshah University of Medical Sciences,Martyr Shahed Behesht, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3432 1439
Email
fateme.dehghan1368@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Korosh Hamzai
Street address
Vice President of Research, Building 2, Kermanshah University of Medical Sciences,Martyr Shahed Behesht, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
k.hamzei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sosan Heydarpour
Position
Associate professor Department of Midwifery, School of Nursing and Midwifery, Kermanshah University
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6717698563
Phone
+98 83 3827 9394
Email
s.heydarpour1394@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan
Position
Department of Midwifery, School of Nursing and Midwifery, Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing and Midwifery, Dolatabad, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6717698563
Phone
+98 83 3432 1439
Email
fateme.dehghan1368@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Part 18, Block 2, alleys action 21, Tang Knsh streets, Zfr- Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6717698563
Phone
+98 83 3432 1439
Email
fateme.dehghan1368@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the research included results
When the data will become available and for how long
12 months
To whom data/document is available
Researchers working in Academia
Under which criteria data/document could be used
Meta-analysis
From where data/document is obtainable
fateme.dehghan1368@gmail.com
What processes are involved for a request to access data/document
Maximum one week
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