MenopauseNCT02496338
Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction
A study testing Training program about menopausal health isues in people with Menopause, run by Gonabad University of Medical Sciences.
Trial summary
The investigators conducted a clinical trial to evaluation the effect of a menopausal health training for Husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Training program about menopausal health isues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Aug 2014
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- living with their spouse
- no history of premature menopause
- no history of hysterectomy
- no history of oophorectomy
- no history of acute disease
- no history of burden chronic disease
Who cannot join
- no participation of spouse in all of training session
- uncompleted all of equation
- favorite to exclude from study
About this study
Official title: Effect of Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction During Transitional Period
The investigators conducted a clinical trial to evaluation the effect of a menopausal health training for Husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause.
Read the detailed description
The investigators applied a menopausal health training program for Husbands of 45-60 years women. The content of menopausal health training program was about the nature of menopause, signs and symptoms, complications, treatment option and health behavior during transitional period. Training program lasted 3 sessions. The investigators assessed quality of life and marital satisfaction using Hildich marital satisfaction questionnaire and Menopause Quality of Life questionnaire(MENQOL), respectively, three month after intervention.
- Conditions
- Menopause
- Being tested
- Training program about menopausal health isues
- Keywords
- Menopause, Quality of Life, Marital Satisfaction, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training program about menopausal health isuesOther
A three sessions raining program about health issues during menopause for spouses of 45-60 years old
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Training program about menopausal health isues Receives: Other: Training program about menopausal health isues |
| Control group | No intervention | No training program about menopausal health isues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
assessing with MENQOL
Measured: 3 months
Secondary outcomes (1)
Marital satisfaction
Hildich Marital satisfaction questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Sadoughi University of Medical Sciences and Health Services
- Responsible party
- Principal investigator, Narjes Bahri, Gonabad University of Medical Sciences
- Investigators
- MahamadAli MorovvatiSharifabad, PhD, Study chair, Yazd University of Medical Sicences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496338
- Sponsor's protocol ID
- 92/11
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction During Transitional Period
- ClinicalTrials.gov ID
- NCT02496338
- Acronym / sponsor ID
- 92/11
- Conditions
- Menopause
- Keywords
- Menopause, Quality of Life, Marital Satisfaction, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Sadoughi University of Medical Sciences and Health Services
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
The investigators conducted a clinical trial to evaluation the effect of a menopausal health training for Husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause.
Detailed description
The investigators applied a menopausal health training program for Husbands of 45-60 years women. The content of menopausal health training program was about the nature of menopause, signs and symptoms, complications, treatment option and health behavior during transitional period. Training program lasted 3 sessions. The investigators assessed quality of life and marital satisfaction using Hildich marital satisfaction questionnaire and Menopause Quality of Life questionnaire(MENQOL), respectively, three month after intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Training program about menopausal health isuesTraining program about menopausal health isues |
| Control group | No intervention | –No training program about menopausal health isues |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- living with their spouse
- no history of premature menopause
- no history of hysterectomy
- no history of oophorectomy
- no history of acute disease
Key exclusion criteria (3 listed)
- no participation of spouse in all of training session
- uncompleted all of equation
- favorite to exclude from study
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 |
|---|---|---|
| Training program about menopausal health isuesA three sessions raining program about health issues during menopause for spouses of 45-60 years old | Other | Intervention group |
Primary outcome
Quality of Life
Time frame: 3 months
assessing with MENQOL
1 secondary outcome
Marital satisfaction
Time frame: 3 months
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 14 Jul 2015.
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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.
MahamadAli MorovvatiSharifabad, PhD study chair
Yazd University of Medical Sicences
Questions about this trial
What is this clinical trial studying?
A study testing Training program about menopausal health isues 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 6 inclusion and 3 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 14 Jul 2015. 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?
Quality of Life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2015.