Comparison of the effectiveness of cognitive-behavioral approach with two methods of guided self-help and group counseling on problematic hot flashes in menopause
Aims: To determine the amount of hot flash in postmenopausal women in experimental and control groups before intervention, immediately after intervention, 8 weeks after intervention and 5 months after intervention.
Design: parallel.
How to do: In the call from health volunteers, the installation of a notice in health centers and midwifery offices will be invited from postmenopausal women. Individuals with entry criteria are randomly divided into three groups of self-help (CBT), group counseling (CBT) and control group.
inclusive criteria: Postmenopausal women aged 45-60; Problem flushing; End of hormone therapy at least 2 months before randomization; Women who continue to treat HF / NS but still sign; Farsi language.
exclusive criteria: Non-hormone therapies such as clonidine; megestrol acetate; selective serotonin reuptake inhibitors; physical or mental disabilities that affect the ability of individual involvement; women under hormone therapy; those with symptoms similar to hot flashes.
Main effect: Problem hot flashes.
Group counseling: 4 weekly cognitive-behavioral counseling sessions for 90 minutes at Shahrood Health Centers.
Self-help group: A preparatory session, a follow-up phone call 2 weeks after the start of the study. Participants in this group receive educational content, will spend an unlimited period of four weeks.
The control group does not receive cognitive-behavioral counseling, but will receive 4 weekly training sessions on bleeding and menopausal symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101135980N2
Registration date:2017-10-24, 1396/08/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Zohreh Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 2774
Email address
asghari.z@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2017-12-06, 1396/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cognitive-behavioral approach with two methods of guided self-help and group counseling on problematic hot flashes in menopause
Public title
Effectiveness of cognitive-behavioral Intervention on menopausal hot flashes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: postmenopausal women aged 45-60; problem flushing (score higher than 2 in HFRS and at least 10 hot flashes per week for at least one month before intervention); end of hormone therapy at least 2 months before randomization; women To treat HF / NS, they still mark and seek further treatment; persian language. Exclusion criteria: non-hormone therapies such as clonidine, Megace (megestrol acetate); selective serotonin reuptake inhibitors (SSRIs); physical or mental disabilities that affect the ability of one's participation; women under hormone therapy; Symptoms of hot flush such as hyperthyroidism, pheochromocytoma and carcinoid syndrome.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences
City
Shahroud
Postal code
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.SHMU.REC.1396.94
Health conditions studied
1
Description of health condition studied
Menopausal Hot flushes
ICD-10 code
N95
ICD-10 code description
N95.1
Primary outcomes
1
Description
Amount problematic hot flashes in menopause
Timepoint
Before the intervention, immediately after the intervention, 8 weeks after the intervention, 5 months after the intervention
Method of measurement
Hot Flush Problem-Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Individuals with inclusion criteria are randomly divided into three groups: Guided Self-Help, group counseling, control group.
Counseling sessions for the CBT group: 4 weekly counseling sessions for 90 minutes at Shahrood Municipal Health Services Center focusing on psychosocial education, stress management, effective respiration, cognitive-behavioral intervention, as well as the determination of individual goals and home-homes. The materials used include PowerPoint, Buccettle, Calcium Tetanol, and Respiratory Techniques.
Category
Behavior
2
Description
Counseling for guide self-help CBT group:Includes an educational session and a telephone counseling, 2 weeks after the start of the study. The participants in this group, Buccett and CD will receive educational content, the duration of the 4-week course was absent.
Category
Behavior
3
Description
The control group does not receive cognitive-behavioral counseling, but in order to reduce the error in the research, the control group will receive 4 weekly training sessions on menstrual bleeding and risk symptoms.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sharif Health Center
Full name of responsible person
Asghari Zohreh
Street address
Shahid Sharif health Center, Meysam Tamar street, Shahid Mostafa Khomeini Boulevard, Imam town.
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan-Emamian
Street address
Central building of Shahroud University of Medical Sciences, 7th Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Soltani Fatemeh
Position
Research Officer
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, 7th Tir square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
pajoohesh@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Taher Khani- Skineh
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, 7th Tir square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
sakinehtaherkhani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Asghari Zohreh
Position
Bachelor of Midwifery
Other areas of specialty/work
Street address
Shahid Sharif Health Services Center, Meysam Temar St., Shahid Mostafa Khomeini Boulevard, Imam Town.
City
Shahroud
Postal code
Phone
+98 23 3239 2774
Fax
Email
asghari.mid94@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)