Determine the effect of group counseling on the quality of life in women with surgical menopause
Design
Clinical trial study phase 2, with control group, based on a specific population (surgical postmenopausal women), with parallel groups, open blind, randomized, sample size: 78 samples
Settings and conduct
This open blind study was conducted in Pasargad Hospital, Tehran, on two groups (intervention and control). In the intervention group, counseling is done on 6 sessions weekly. Each session lasts for 45 minutes.The control group receives routine individual counseling . Before the intervention, after the intervention, one and three months after the end of the intervention, the quality of life score in each group is measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Postmenopausal women due to hysterectomy plus bilateral oophorectomy or bilateral oophorectomy that they had experienced menopausal symptoms last month and between the ages of 35-55 years,
2-Married, 3-literate
Exclusion criteria: 1-Use of hormone therapy in the last six months 2- -Use of tobacco or alcohol
Intervention groups
In the intervention group, group counseling is done on 6 sessions weekly. Each session lasts for 45 minutes.Group counseling is done based on the GATHER method.Each session has a specific topic.The control group receives routine individual counseling about menopausal symptoms.
Main outcome variables
Quality of life in postmenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038302N4
Registration date:2018-12-30, 1397/10/09
Registration timing:retrospective
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Mansoureh Yazdkhasti
Name of organization / entity
Alborz University medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 8856
Email address
m.yazdkhasti@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling on the quality of life among postmenopausal women by surgical method
Public title
Effect of group counseling on the quality of life among postmenopausal women by surgical method
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women due to hysterectomy plus bilateral oophorectomy or bilateral Oophorectomy that they had experienced menopausal symptoms last month
Married
Literate
Exclusion criteria:
Use of hormone therapy over the past six months
use of Tobacco or alcohol
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done simple random, individually,and open blind.First, based on the random number table, the numbers are read from left to right. Then, paired numbers are considered for the intervention group and the singular
numbers for the control group.In this way, the random allocation of the two groups is done.In the intervention group, group counseling is performed in 6 sessions (once every week) in 90 minutes. In the control group, individual routine counseling is performed.
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 alborz university of Medical sciences
Street address
NO. 5, Kohnavard Blvd, Dadgostari Street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.Abzums .REC.1396.214
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Menopause quality of life
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Measurement tool is " menopausal quality of life Hildich questionnaire".
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: , 6 sessions per week, they receive group counseling according to the GATHER method.Each session will be 45 minutes.The subject of each session is planned according to menopausal symptoms.Session 1: Preparation for Menopause, Session 2: Vasomotor Signs, Session 3: Psycho social Symptoms, Session 4: Physical Symptoms, Session , 5: Sexual Symptoms, Session Six: Changing life style
Category
Lifestyle
2
Description
Control group: The control group receives individual routine counseling
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasargad hospital
Full name of responsible person
Mansoureh Yazdkhasti
Street address
No. 132,Shariati Ave, Taleghani Blvd,Tehran
City
Karaj
Province
Alborz
Postal code
1423586541
Phone
+98 26 3433 6422
Email
Mansoyazd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohamad NoriSepehr
Street address
No.65, Safarian Ave, Shams Blvd, Karaj Town
City
Karaj
Province
Alborz
Postal code
1414557975
Phone
+98 26 3464 4720
Email
M.Norisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
The Alborz University of Medical Sciences
Full name of responsible person
Mansoureh Yazdkhasti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 47, Baghestan Ave, Hassanabad Blvd, Karaj Town
City
Karaj
Province
Alborz
Postal code
1412556885
Phone
+98 26 3433 2720
Email
Mansoyazd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mansoureh Yazdkhasti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No.47, Baghestan Ave, Hassanabad Blvd, Karaj Town
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3430 1616
Email
Mansoyazd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The Alborz University of Medical Sciences
Full name of responsible person
Mansoureh Yazdkhasti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
NO.47, OOge Ave, HassanAbad Blvd, Karaj Town
City
Karaj
Province
Alborz
Postal code
3131614171
Phone
+98 26 3432 3008
Email
Mansoyazd@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available