Menopausal Health Training for Husbands on Women's Qualit... | NCT02496338

Studies
Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction

NCT02496338

Sponsor

Gonabad University of Medical Sciences

Status

Completed

Last Update Posted

Jul 14, 2015Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Menopause

Interventions

Training program about menopausal health isues

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jul 8, 2015

First Submission Date that Met QC Criteria

Jul 13, 2015

First Posted Date

Jul 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Narjes Bahri, Faculty Member in Department of Midwifery, Gonabad University of Medical SciencesPrincipal Investigator

Lead Sponsor

Gonabad University of Medical SciencesOTHER

Collaborators

Name	Class
Shahid Sadoughi University of Medical Sciences and Health Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Training program about menopausal health isues	Other: Training program about menopausal health isues
Control group	No Intervention	No training program about menopausal health isues

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training program about menopausal health isues	Other	A three sessions raining program about health issues during menopause for spouses of 45-60 years old	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life	assessing with MENQOL	3 months

Secondary Outcomes

Measure	Description	Time Frame
Marital satisfaction	Hildich Marital satisfaction questionnaire	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no participation of spouse in all of training session
uncompleted all of equation
favorite to exclude from study

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MahamadAli MorovvatiSharifabad, PhD	Yazd University of Medical Sicences	Study Chair

Locations

Not provided