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The Relaxation Exercise and Social Support Trial

The Relaxation Exercise and Social Support Trial: Does a community based psycho-social intervention (combined structured social support groups and progressive relaxing exercises) alter complaints from medically unexplained vaginal discharge among low-income married women, aged 18 - 49 years and residing in Hay el Sellom?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98441241
Enrollment
204
Registered
2010-09-10
Start date
2009-03-30
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medically unexplained vaginal discharge Urological and Genital Diseases Vaginal discharge

Interventions

The intervention package will be given for six weeks. The package includes: combined trainer-supervised relaxation exercises (twice per week for 30 minutes/session) and group discussions (twice per we

Sponsors

American University of Beirut (Lebanon)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Currently married women, 18 - 49 years of age 2. Women who report of symptoms of MUVD 3. Women who score low to moderate levels of common mental disorders (CMDs), based on the study screening tool for common mental disorders (Hopkins Checklist 25) 4. Women who are willing to take part in the study by signing an informed consent after explaining the study process 5. Women who upon screening have none of the exclusion criteria listed below

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Menopause. Menopausal women are excluded (definition of menopause: at least one year since last menses) because: 2.1. Frequency of MUVD among older is much lower 2.2. Young women in the reproductive age share different concerns than older women 2.3. The physical activity component of the intervention may not be suitable for older women 2.4. Older women suffer from a distinct set of physiological symptoms when compared to women in the reproductive age group like hypersomnia, hot flashes, and so on. Also, menopausal women suffer from explained vaginal discharge due to vaginal dryness. 3. Less than 8 weeks postpartum 4. Hysterectomy. Women with hysterectomy are excluded because they could be predisposed to some types of infections as a result of the removal of the uterus. 5. Women who score very low or severe levels of CMDs 6. Women who report having been treated for severe mental illness such as bi-polar depression, and schizophrenia

Design outcomes

Primary

MeasureTime frame
Reported MUVD at six months (which is also assessed at six weeks upon the completion of the intervention for the intervention group). A woman is considered to have MUVD, if she reported a complaint of vaginal discharge as assessed by the question: "are you complaining currently from vaginal discharge?" and is concurrently not suffering from any RTIs, as confirmed by pelvic exam and laboratory tests (using swabs). Further questions will also be asked of the women to note whether or not they are bothered by MUVD, as well as to indicate the colour, odour, thickness, consistency and frequency. Besides, relevant health service use such as consultations for MUVD and associated treatments will also be explored.

Secondary

MeasureTime frame
1. Common mental disorder (CMD): the Hopkins Symptom Checklist 25 (HSCL-25) (individual scores on anxiety ranging between 2.0 - 3.2 and/or depression ranging between 2.1 - 3.3 are considered symptomatic) will be used to assess common mental disorders. 2. Somatisation: will be assessed using The Scale for Assessment of Somatic Symptoms (SASS) Other measures/cofactors included: 3. Socio-demographic factors: age, education, employment status, family composition (presence of extended family members), number of children present (by age of each child), housing tenure (owned or rental), number of rooms, and household income 4. Women's reproductive and obstetric history (e.g. pregnancies, live births, abortions, still births) 5. Social support: will be assessed using questions from the Urban Health Survey, already translated into Arabic Timing of outcome assessment: The outcomes relating to CMDs will be assessed at screening, 1.5 and six months after randomisation, and somatisation were assessed at baseline and six months. The laboratory tests which will be conducted to rule out RTIs were assessed at baseline and at six months. The socio-demographic characteristics and reproductive history of the women will be assessed only at baseline, while, social support factors will be assessed at both baseline and at six months.

Countries

Lebanon

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026