NCT02496338

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 8, 2015

Last Update Submit

July 13, 2015

Conditions

Menopause

Keywords

MenopauseQuality of LifeMarital Satisfactiontraining

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    assessing with MENQOL

    3 months

Secondary Outcomes (1)

  • Marital satisfaction

    3 months

Study Arms (2)

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

Training program about menopausal health isuesOTHER

A three sessions raining program about health issues during menopause for spouses of 45-60 years old

Intervention group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • MahamadAli MorovvatiSharifabad, PhD

    Yazd University of Medical Sicences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Member in Department of Midwifery

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 14, 2015

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

July 14, 2015

Record last verified: 2015-07