A study to find the effectiveness of mindfulness-based stress reduction given by nurse to improve the quality of life, physical health, psychosocial health and sexual function using smart phone of early post-menopausal women in the community of Sikkim

Nurse led mindfulness-based stress reduction (NL-MBSR) through smart phone monitoring on quality of life, physical health , psychosocial health and sexual function: A Community Based Randomized Waitlist Control Trial on early post-menopausal women of Sikkim.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084701

Enrollment

110

Registered

2025-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

None listed

Interventions

Intervention1: Nurse Led Mindfulness Based Stress Reduction: The intervention group will receive 8 weeks of stress-reduction skills which includes mindfulness meditation like body scan, sitting and wa

Eligibility

Inclusion criteria

Inclusion criteria: Early Postmenopausal women experience moderate to severe symptoms as per MENQOL score between 61-95 who can read and write Nepali/Hindi/ English Who has smart phone Without gross visual, hearing, and speech impairment that can interfere with therapy

Exclusion criteria

Exclusion criteria: Women on hormonal contraceptive pills Women taking hormone replacement therapy (HRT) Artificial menopause- hysterectomy or ovarian surgery Who have practiced MBSR therapy in the past. Who do not provide written informed consent to participate.

Design outcomes

Primary

Measure	Time frame
1. Quality-of-life with Menopause Specific Quality of Life Questionnaire (MENQOL) 2. Psychosocial health with Mindful Attention Awareness Scale (MAAS) 3. Sexual function with Female Sexual Function Index domain (FSFI) for sexual health 4.Acceptability to Nurse Lead- Mindfulness-Based Stress Reduction with Satisfaction Rating Scale Timepoint: The time point will be baseline and every week for 8 weeks.	—

Measure

Time frame

1. Quality-of-life with Menopause Specific Quality of Life Questionnaire (MENQOL) 2. Psychosocial health with Mindful Attention Awareness Scale (MAAS) 3. Sexual function with Female Sexual Function Index domain (FSFI) for sexual health 4.Acceptability to Nurse Lead- Mindfulness-Based Stress Reduction with Satisfaction Rating Scale Timepoint: The time point will be baseline and every week for 8 weeks.

—

Secondary

Measure	Time frame
To validate the content for Nurse led mindfulness-based stress reduction (NL-MBSR) on menopausal health of early post-menopausal women To estimate the quality of life, physical health, psychosocial health and sexual function of early post-menopausal women To determine the changes in quality of life, physical health, psychosocial health and sexual function of early post-menopausal women between intervention group (IVG) and wait list control group (WLCG) To determine association between different socio-demographic variables with quality of life, physical health, psychosocial health and sexual function of early post-menopausal women To estimate the acceptability of Nurse led mindfulness-based stress reduction (NL-MBSR) among early post-menopausal women who experience a moderate to severe range of symptoms in menopause? Timepoint: 3years	—

Measure

Time frame

To validate the content for Nurse led mindfulness-based stress reduction (NL-MBSR) on menopausal health of early post-menopausal women To estimate the quality of life, physical health, psychosocial health and sexual function of early post-menopausal women To determine the changes in quality of life, physical health, psychosocial health and sexual function of early post-menopausal women between intervention group (IVG) and wait list control group (WLCG) To determine association between different socio-demographic variables with quality of life, physical health, psychosocial health and sexual function of early post-menopausal women To estimate the acceptability of Nurse led mindfulness-based stress reduction (NL-MBSR) among early post-menopausal women who experience a moderate to severe range of symptoms in menopause? Timepoint: 3years

—

Countries

India

Contacts

Public ContactDr Barkha Devi

Sikkim Manipal Institute of Medical Sciences

drbidita@gmail.com9641500658

Outcome results