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The effect of education-based cognitive-behavioral approach on beliefs, behaviors, and symptoms of hot flashes and insomnia among menopausal transition women: A randomized controlled trial

Protocol summary

Study aim
The effect of education-based cognitive-behavioral approach on beliefs, behaviors, and symptoms of hot flashes and insomnia among menopausal transition women
Design
A randomized controlled clinical trial with parallel groups, involving 64 patients in each group. Participants will be allocated to the intervention and control groups using random block assignments of 2 and 4.
Settings and conduct
Eligible women are randomly assigned to intervention or control groups. Before the intervention, all complete symptom and characteristic questionnaires. Intervention group: Attends six 2-hour sessions over 6 weeks at Shahid Fayazbakhsh Gonabad Health Center, covering psychoeducation, stress management, breathing techniques, and cognitive distortions. Control group: Receives only an educational booklet on menopause. After the intervention, both groups retake the questionnaires to assess changes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 45-55, Natural menopause, Hot flashes/night sweats (score more than 2) for 1 month, Insomnia for 1 month. Exclusion criteria: Medications affecting hot flashes, Medical/psychological conditions preventing participation, Special diet/supplements affecting menopause, Breast cancer (less than 6 months post-treatment).
Intervention groups
In the intervention group, participants will attend 2-hour weekly sessions for 6 weeks (total 12 hours). Sessions will focus on cognitive-behavioral techniques, stress management, and recognizing cognitive distortions. The control group will receive an educational booklet on menopause and symptom management.
Main outcome variables
Severity and frequency of hot flashes, hot flash beliefs, hot flash behaviors, the severity of insomnia.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250120064452N1
Registration date: 2025-04-10, 1404/01/21
Registration timing: prospective

Last update: 2025-04-10, 1404/01/21
Update count: 0
Registration date
2025-04-10, 1404/01/21
Registrant information
Name
Elahe AkramiNejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 2551
Email address
eliakraminezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-10, 1404/02/20
Expected recruitment end date
2025-09-11, 1404/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education-based cognitive-behavioral approach on beliefs, behaviors, and symptoms of hot flashes and insomnia among menopausal transition women: A randomized controlled trial
Public title
The effect of education-based cognitive-behavioral approach on beliefs, behaviors, and symptoms of hot flashes and insomnia among women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Completion of the Informed Consent Form Iranian and a resident of Gonabad city Ability to read and write Menopause transition years (45 to 55 years) In the event of menopause, the menopause must have occurred naturally (not due to surgery) Having hot flashes/night sweats (a score above 2 on the hot flash rating scale) for at least 1 month Having insomnia for at least 1 month
Exclusion criteria:
Use of effective medications for hot flashes (Estrogen and Progesterone, SSRIs, and SNRIs, Antihypertensive and Anticonvulsant drugs) Presence of medical or psychological conditions that prevent participation in the study Occurrence of a stressful event in the past six months (as reported by the participant) Specific diet and soy supplements consumption or other plant-based compounds affecting menopausal symptoms, including isoflavone consumption (as reported by the participant) Breast cancer (provided that less than six months have passed since the end of treatment) Presence of medical conditions that may affect hot flashes (as reported by the participant) Use of prescription or over-the-counter treatments for hot flashes in the past 30 days (as reported by the participant) Use of sex steroid hormones or hormonal contraceptives drugs (within the past 2 months) (as reported by the participant) History of treatment or training based on cognitive behavioral therapy
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling, randomized allocation method, using permuted blocks of size 2 and 4 into two groups: experimental and control
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 Gonabad Medical University
Street address
Campus of Gonabad University of Medical Sciences, Asian Highway Margin, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.GMU.REC.1403.188

Health conditions studied

1

Description of health condition studied
Menopause, Hot Flash, Insomnia
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Hot flash severity on the Hot Flash Frequency And Problem Rating Scale
Timepoint
Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention
Method of measurement
Hot Flash Frequency And Problem Rating Scale

2

Description
Hot flash frequency on the Hot Flash Frequency And Problem Rating Scale
Timepoint
Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention
Method of measurement
Hot Flash Frequency And Problem Rating Scale

3

Description
insomnia severity on the Insomnia Severity Index
Timepoint
Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention
Method of measurement
Insomnia Severity Index

4

Description
Night sweats score on Hot Flash Frequency And Problem Rating Scale
Timepoint
Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention
Method of measurement
Hot Flash Frequency And Problem Rating Scale

5

Description
Hot Flash Behavior score on the Hot Flush Behavior Scale
Timepoint
Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention
Method of measurement
Hot Flush Behavior Scale

6

Description
Hot Flash Beliefs Score on the Hot Flash Beliefs Scale
Timepoint
Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention
Method of measurement
Hot Flash Beliefs Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Two-hour training sessions, once a week, for six weeks. A cognitive-behavioral approach will be used to structure the content of the sessions, focusing on psychoeducation, stress management, proper breathing, training and identification of cognitive errors, and other items related to the cognitive-behavioral approach, including setting individual goals and assigning homework. The training sessions will use lectures with slides and clips on the topic of relaxed/rapid breathing, and educational pamphlets.
Category
Behavior

2

Description
Control group: Participants will receive an educational booklet about menopause, its symptoms, and strategies for reducing vasomotor symptoms.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Fayyazbakhsh Comprehensive Health Center, Gonabad
Full name of responsible person
Narjes Bahri
Street address
Shahid Fayyaz Bakhsh Comprehensive Health Center No. 1, Next to the Blood Transfusion Organization, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691977469
Phone
+98 51 5722 2598
Email
info@gmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research and Technology of Gonabad University of Medical Sciences
Street address
Campus of Gonabad University of Medical Science , Asian Highway (SENTO Road), Gonabad, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Narjes Bahri Binabaj
Position
Associate Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Campus of Gonabad University of Medical Sciences, Asian Highway Margin, Gonabad, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 5714
Email
nargesbahri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes Bahri Binabaj
Position
Associate Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Campus of Gonabad University of Medical Sciences, Asian Highway Margin, Gonabad, Razavi Khorasan, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 5714
Email
nargesbahri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elahe AkramiNejad
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
2nd Floor, No. 38, Emamat 60, Emamat street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188113542
Phone
+98 51 3605 2551
Fax
Email
eliakraminezhad@gmail.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
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