Nurse-Led,Digitally Supported Mindfulness-Based Stress Reduction for Early Postmenopausal Women: Protocol for a Randomized Waitlist-Controlled Trial

Abstract

Background:

Early postmenopause is characterized by persistent menopausal symptoms that may impair quality of life. Globally, early postmenopausal care is constrained by sociocultural barriers and limited availability of nurse-led, nonpharmacological services. Mindfulness-Based Stress Reduction (MBSR), aligned with holistic nursing philosophy, lacks evidence in culturally adapted, nurse-led, digitally supported formats for early postmenopausal women.

Purpose:

To evaluate the feasibility and acceptability of a nurse-led digitally supported MBSR program for early postmenopausal women on quality of life and holistic health indicators.

Methods:

A total of 128 early postmenopausal women from both rural and urban areas will be recruited for this community-based randomized waitlist-controlled trial. After screening and informed consent, participants will be randomized to an eight-week nurse-led MBSR intervention or a waitlist control group receiving routine care. The digitally delivered intervention includes mindfulness meditation, mindful breathing, gentle yoga, attention-based practices, and supervised daily practice. Menopause-related quality of life measured by the Menopause-Specific Quality of Life Questionnaire is the primary outcome; secondary outcomes include mindfulness, sexual function, and program acceptability. Assessments will occur at baseline and post-intervention, with weekly MENQOL tracking.

Conclusions:

This study is expected to provide evidence supporting feasible, holistic, nurse-led, nonpharmacological care for early postmenopausal women in the community settings.

Keywords

mindfulness holistic nursing menopause

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References

Ahuja

(2016). Age of menopause and determinants of menopause in women of India: A meta-analysis. The Journal of Obstetrics and Gynecology of India, 66(Suppl 1), 117–123. https://doi.org/10.4103/0976-7800.191012

Amin

S. M.

El-Gazar

H. E.

Zoromba

M. A.

El-Sayed

M. M.

Awad

A. G. E.

Atta

M. H. R.

(2025). Mindfulness for menopausal women: Enhancing quality of life and psychological well-being through a randomized controlled intervention. Journal of Nursing Scholarship, 57(4), 563–575. https://doi.org/10.1111/jnu.70003

Brown

K. W.

Ryan

R. M.

(2003). The Mindful Attention Awareness Scale (MAAS): Development and psychometric properties. Journal of Personality and Social Psychology, 84(4), 822–848. https://doi.org/10.1037/0022-3514.84.4.822

Carmody

Baer

R. A.

(2008). Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms. Journal of Behavioral Medicine, 31(1), 23–33. https://doi.org/10.1007/s10865-007-9130-7

Carmody

J. F.

Crawford

Salmoirago-Blotcher

Leung

Churchill

Olendzki

(2011). Mindfulness training for coping with hot flashes: Results of a randomized trial. Menopause (New York, N. Y.), 18(6), 611–620. https://doi.org/10.1097/gme.0b013e318204a05c

Cramer

Lauche

Langhorst

Dobos

(2012). Effectiveness of yoga for menopausal symptoms: A systematic review and meta-analysis of randomized controlled trials. Evidence-Based Complementary and Alternative Medicine, 2012, Article 863905. https://doi.org/10.1155/2012/863905

Dalal

P. K.

Agarwal

(2015). Postmenopausal syndrome. Indian Journal of Psychiatry, 57(Suppl 2), S222–S232. https://doi.org/10.4103/0019-5545.161483

Davis

S. R.

Lambrinoudaki

Lumsden

Mishra

G. D.

Pal

Rees

Santoro

Simoncini

(2015). Menopause. Nature Reviews Disease Primers, 1, Article 15004. https://doi.org/10.1038/nrdp.2015.4

Freeman

E. W.

Sherif

(2007). Prevalence of hot flushes, night sweats, and other menopausal symptoms. Climacteric, 10(3), 197–214. https://doi.org/10.1080/13697130601181486

10.

Goyal

Singh

Sibinga

E. M. S.

Gould

N. F.

Rowland-Seymour

Sharma

Berger

Sleicher

Maron

D. D.

Shihab

H. M.

Ranasinghe

P. D.

Linn

Saha

Bass

E. B.

Haythornthwaite

J. A.

(2014). Meditation programs for psychological stress and well-being: A systematic review and meta-analysis. JAMA Internal Medicine, 174(3), 357–368. https://doi.org/10.1001/jamainternmed.2013.13018

11.

Harlow

S. D.

Gass

Hall

J. E.

Lobo

Maki

Rebar

R. W.

Sherman

Sluss

P. M.

de Villiers

T. J.

(2012). Executive summary of the Stages of Reproductive Aging Workshop +10: Addressing the unfinished agenda of staging reproductive aging. The Journal of Clinical Endocrinology & Metabolism, 97(4), 1159–1168. https://doi.org/10.1210/jc.2011-3362

12.

Hilditch

J. R.

Lewis

Peter

van Maris

Ross

Franssen

Guyatt

G. H.

Norton

P. G.

Dunn

(1996). A menopause-specific quality of life questionnaire: Development and psychometric properties. Maturitas, 24(3), 161–175. https://doi.org/10.1016/S0378-5122(96)82006-8

13.

IBM Corp. (2015). IBM SPSS Statistics for Windows (Version 23.0) [Computer software]. IBM Corp.

14.

International Council for Harmonisation. (2016). ICH harmonised guideline: Integrated addendum to ICH E6(R2) – Good clinical practice. https://www.ich.org.

15.

Jongebloed

Anderson

Winter

Nguyen

Huggins

C. E.

Savira

Cooper

Yuen

Peeters

Rasmussen

Reddy

Crowe

Bhoyroo

Muhammad

Ugalde

(2024). The digital divide in rural and regional communities: Implications for digital health technology use. BMC Research Notes, 17(1), Article 90. https://doi.org/10.1186/s13104-024-06687-x

16.

Kabat-Zinn

(1990). Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. Delta.

17.

Nappi

R. E.

Lachowsky

(2009). Menopause and sexuality: Prevalence of symptoms and impact on quality of life. Maturitas, 63(2), 138–141. https://doi.org/10.1016/j.maturitas.2009.03.021

18.

Prasad

J. B.

Chhabra

Singh

(2021). Age at menopause and correlates in Indian women: A systematic review. Maturitas, 148, 47–56. https://doi.org/10.1016/j.maturitas.2021.01.013

19.

Rosen

Brown

Heiman

Leiblum

Meston

Shabsigh

Ferguson

D’Agostino

(2000). The Female Sexual Function Index (FSFI): A multidimensional self-report instrument. Journal of Sex & Marital Therapy, 26(2), 191–205. https://doi.org/10.1080/009262300278597

20.

Roshini

R. A.

Stanly

A. M.

Samya

(2025). Prevalence of menopausal symptoms and their impact on quality of life among women aged 41–60 years in a rural area. Journal of Family Medicine and Primary Care, 14(9), 3912–3919. https://doi.org/10.4103/jfmpc.jfmpc_2101_24

21.

Schulz

K. F.

Altman

D. G.

Moher

(2010). CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. BMJ, 340, c332. https://doi.org/10.1136/bmj.c332

22.

SPIRIT Initiative. (2025). SPIRIT 2025 statement: Updated guidelines for protocols of randomized trials. https://www.spirit-statement.org.

23.

The North American Menopause Society. (2022). The 2022 hormone therapy position statement of the North American Menopause Society. Menopause (New York, N. Y.), 29(7), 767–794. https://doi.org/10.1097/GME.0000000000002028

24.

World Health Organization. (2019). Process of translation and adaptation of instruments. https://www.who.int.

25.

World Health Organization. (2024). Menopause. https://www.who.int/news-room/fact-sheets/detail/menopause.

26.

World Medical Association. (2013). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053

27.

Yazdani Aliabadi

Javadnoori

Saki Malehi

Aslani

(2021). Effects of mindfulness-based stress reduction on menopause-specific quality of life: A randomized controlled trial. Complementary Therapies in Clinical Practice, 43, Article 101398. https://doi.org/10.1016/j.ctcp.2021.101398