MenopauseNCT03313739
An Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women
A study testing An Educational Program in people with Menopause, run by Gonabad University of Medical Sciences.
Trial summary
This study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women. Read more about this study
- Who is it for?
- Ages 46 to 57 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- An Educational Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2016to 23 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 57 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- menopausal women(1-5 years after menopause)
- no history of hysterectomy
- no history of oophorectomy
- literacy for reading and writing
Who cannot join
- no interest for continuing the study
- no participating in all educational sessions
About this study
Official title: The Effect of an Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women
This study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women.
Read the detailed description
In this study 60 menopausal women randomly allocated to intervention group(n=30) and control group(n=30).
Intervention group participated in an educational program that had designed in four sessions based on teach back method. Control group revived no education.
- Conditions
- Menopause
- Being tested
- An Educational Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Educational ProgramOther
An educational program was designed for self-care during menopause using teach back method.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An Educational Program Receives: Other: An Educational Program |
| Control group | No intervention | This group(n=30) received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care practice
self-care practice regard menopausal health was measured using a researcher made questionnaire
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start12 Jul 2016
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narjes Bahri, Gonabad University of Medical Sciences
- Investigators
- Narjes Bahri, PhD, Study director, GMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313739
- Sponsor's protocol ID
- P/4/69
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bahri N, Yoshany N, Morowatisharifabad MA, Noghabi AD, Sajjadi M. The effects of menopausal health training for spouses on women's quality of life during menopause transitional period. Menopause. 2016 Feb;23(2):183-8. doi: 10.1097/GME.0000000000000588.
PubMed 26783984
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women
- ClinicalTrials.gov ID
- NCT03313739
- Acronym / sponsor ID
- P/4/69
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women.
Detailed description
In this study 60 menopausal women randomly allocated to intervention group(n=30) and control group(n=30).
Intervention group participated in an educational program that had designed in four sessions based on teach back method. Control group revived no education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: An Educational ProgramAn Educational Program |
| Control group | No intervention | –This group(n=30) received no intervention. |
Who may qualify
- Ages
- 46 to 57 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- menopausal women(1-5 years after menopause)
- no history of hysterectomy
- no history of oophorectomy
- literacy for reading and writing
Key exclusion criteria (2 listed)
- no interest for continuing the study
- no participating in all educational sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An Educational ProgramAn educational program was designed for self-care during menopause using teach back method. | Other | Intervention group |
Primary outcome
self-care practice
Time frame: one month
self-care practice regard menopausal health was measured using a researcher made questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Results publication: PubMed 26783984Bahri N, Yoshany N, Morowatisharifabad MA, Noghabi AD, Sajjadi M. The effects of menopausal health training for spouses on women's quality of life during menopause transitional period. Menopause. 2016 Feb;23(2):183-8. doi: 10.1097/GME.0000000000000588.
- related paperLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narjes Bahri, PhD study director
GMU
Questions about this trial
What is this clinical trial studying?
A study testing An Educational Program in people with Menopause, run by Gonabad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-care practice (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.