Supporting girls in Nepal to cope with period pain through menstrual health and justice workshops

ISRCTN	ISRCTN61989646
DOI	https://doi.org/10.1186/ISRCTN61989646
Secondary identifying numbers	UKRI Horizon Europe Guarantee EP/X02265X/1

Submission date: 10/06/2025
Registration date: 20/06/2025
Last edited: 20/06/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Menstruation is a normal and healthy part of life, but in many places it is seen as shameful or taboo. This is especially the case in Nepal, where nearly all women and girls are restricted from activities during their period, including joining in with festivals/celebrations, eating/drinking some things, and sleeping in their home. Girls often do not know about menstruation when they have their first period and face a lot of misinformation.
Period pain (dysmenorrhoea) affects up to 90% of girls and can have a substantial impact on girls’ health and wellbeing, and stop them going to school. However, there is very little research on how best to help girls manage this pain, especially in settings where access to healthcare is limited.
This study aims to test whether a programme of guided workshops that teach girls about their periods, menstrual pain, and practical coping skills can reduce the impact of pain on their daily lives. The programme also includes workshops for mothers and wider members of the community to help reduce stigma and improve knowledge in the wider community.

Who can participate?
Girls aged 13-18 years old

What does the study involve?
The menstrual health and justice (MeJARa) programme is a series of 12 interactive workshops for adolescent girls. Mothers (or caregivers) and wider community members will take part in a shorter programme of workshops.
The programme covers the things that matter most to girls about menstruation. The programme has been developed by a team from the UK and Nepal after research talking to girls in Nepal about what they want, as well as their families and wider community.
This programme will take place in two districts of Nepal (Kaski and Surkhet). Girls will attend weekly 60-minute sessions in groups of 20, led by a trained facilitator in their community. Local facilitators will be trained by the study team from the UK and Nepal.
The girls’ workshops will include five topic areas:
• Menstrual health and biology;
• Healthy lifestyle habits;
• Pain psychoeducation;
• Pain coping skills;
• Communication skills.
The mothers/caregivers and community members workshops cover three topics after an introductory session to encourage them to support the programme:
• Menstrual cycle and beliefs;
• Menstrual pain education;
• Ways to support girls’ menstrual health.
Adults will join the girls for a final session which will be a celebration of completing the programme and closing ceremony.

A questionnaire will be used to assess girls and mothers/caregivers menstrual experiences, knowledge and attitudes, with a focus on pain. The questionnaire will take place before the workshops begin, straight after they finish, and a year later to see if the programme has had any lasting impact. Communities will be randomly assigned to receive the workshops or not, with half the girls in communities running the MeJARa programme and half the girls in communities with none.

What are the possible benefits and risks of participating?
Benefits:
• Girls may feel more confident and better able to manage menstrual pain;
• Girls may learn valuable information about the menstrual cycle and practical coping strategies to improve their menstrual experiences;
• Girls may learn how to advocate for themselves through communication strategies thus empowering them and improving communication within families and communities;
• Stigma around menstruation may be reduced as girls, their parents (or caregivers), and wider community members will learn facts about menstruation and pain and share experiences.
Risks:
• Girls may feel upset or frustrated if they are still expected to follow menstrual restrictions;
• Girls may not be able to practice the skills they have learned for coping with pain if their families are not supportive and their pain might continue to be minimised and dismissed;
• Some participants may feel shy or uncomfortable talking about menstruation, especially to begin with. They will not be asked to share anything they are uncomfortable with and all sessions will be run in a safe, respectful, and supportive environment by trained facilitators.

Where is the study run from?
The MeJARa study is being run by the University of Bath, UK and the Center for Research on Environment Health and Population Activities (CREHPA), Nepal. It takes place in community venues in two district of Nepal: Surkhet, Karnali province and Kaski, Gandaki province.

When is the study starting and how long is it expected to run for?
December 2022 to November 2027, with the workshops planned for July to October 2025

Who is funding the study?
UK Research and Innovation (UKRI)

Who is the main contact?
1. Dr Melanie Channon
mdc51@bath.ac.uk
2. Dr Mahesh Puri, Co-Director, CREHPA
mahesh@crehpa.org.np

Study website

Contact information

Dr Melanie Channon
Public, Scientific, Principal Investigator

3E, Department of Social and Policy Sciences, University of Bath, Claverton Down
Bath
BA2 7AY
United Kingdom

ORCID ID	0000-0003-4820-0928
Phone	+44 1225 384513
Email	mdc51@bath.ac.uk

Study information

Study design	Cluster randomized-controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Effect of group-based menstrual justice workshops and psychoeducation on menstrual pain interference among adolescent girls in Nepal: a cluster randomised-controlled trial (MeJARa)
Study acronym	MeJARa
Study objectives	The primary objective is to reduce menstrual pain interference in girls. Primary hypothesis: H1: Girls who receive the psychological intervention will have lower pain interference post-intervention and at follow-up as compared to the control group. H2: There will be no difference in adverse events reported between intervention and control groups.
Ethics approval(s)	1. Approved 23/06/2023, Nepal Health Research Council (Ramshah Path, PO Box: 7626, Kathmandu, N/A, Nepal; +977 14254220; nhrc@nhrc.gov.np), ref: 375/2023 2. Approved 19/07/2023, University of Bath (Claverton Down, Bath, BA2 7AY, Nepal; -; research-ethics@bath.ac.uk), ref: 0076-478
Health condition(s) or problem(s) studied	Dysmenorrhea and menstrual health in adolescent girls
Intervention	Menstrual education and coping skills The intervention has been designed to be simple and replicable, with the intention that should it be found to be effective and acceptable; it can continue to be used by the local communities outside of the remit of this research. Each girl will receive a resource booklet summarising key pain coping skills and a period tracker. This replicability has been the foundation for many features of the intervention, such as the handout materials being black and white and only a couple of pages for each session, and fact-based so that they could be used for any audience. The facilitation guide is more detailed and provides scripts and lesson plans which are specifically targeted to the audience. The intervention development was informed by qualitative interviews conducted prior to the intervention development which explored what girls and stakeholders wanted from an intervention, pain and medication beliefs, and understandings of pain and medication. Girls intervention The intervention delivered to the girls will consist of 12 sessions of 60 minutes. The intervention will be delivered in groups on a weekly basis. The intervention consists of five components: 1) Menstrual education: educate the girls about the biology of menstruation, products and care during menstruation. 2) Lifestyle factors: information about nutrition, hydration and sleep. 3) Pain psychoeducation: education about the biopsychosocial influences of pain and address misbeliefs about pain and medication that emerged from qualitative research prior to the intervention. 4) Pain coping skills: providing the girls with pain coping skills such as relaxation techniques, distraction, and visualisation to manage menstrual pain in the moment. 5) Communication and skills practice: help girls communication pain to stakeholders and family members. Practice skills. Parent and stakeholder intervention Parents and stakeholders will receive a shorter intervention compared to girls, consisting of 4 sessions: 1) Welcome and introduction 2) Menstrual cycle and beliefs 3) Menstrual pain education 4) Ways to support girls with menstrual health/justice Stakeholders will then join the girls for a final session which is a celebration of completing the intervention and closing ceremony. Intervention delivery and training of healthcare facilitators The intervention will be delivered by local Nepali facilitators who will have been trained to deliver the intervention by the study team (consisting of Nepali and British members) in a ‘train the trainer’ approach. Training will take 5 days. The intervention materials have been designed in collaboration with local Nepali collaborators. The co-creation of the materials with Nepali collaborators ensures that all aspects are culturally appropriate and applicable. Clusters will be stratified by district (Surkhet and Kaski) and then by community types (rural and urban), resulting in four cluster groups (Surkhet urban, Surkhet rural, Kaski urban, Kaski rural) with 12 clusters in each. Clusters will be allocated to the intervention or control arm via a computer generated random number assignment, with half being assigned to the intervention group within each strata.
Intervention type	Behavioural
Primary outcome measure	Pain interference measured using a 12 item scale adapted to the Nepali context, at baseline, post-intervention, and at 1-year follow up.
Secondary outcome measures	The secondary outcome measures will be assessed at baseline, at the end of the intervention, and 1-year after the intervention. The following outcomes are measured for the adolescent girls and collected via in-person enumerator administered questionnaire: 1. Pain intensity of the last menstrual period measured using the visual analogue scale (VAS) 2. Usual pain intensity during menstruation measured using the visual analogue scale (VAS) 3. Depression measured using the Nepali Depression Self Rating Scale (NDSRS) 4. Anxiety measured using the GAD-7 5. Pain catastrophising measured using the Pain Catastrophising Scale for Children (PCS-C) 6. Beliefs about menstrual pain using the Pain Beliefs Questionnaire (PBQ) 7. Menstrual practices measured using the Menstrual Practice Needs Scale (MNPS) 8. Knowledge of the menstrual cycle using eight true/false statements 9. Menstrual stigma measured using the Nepali Menstrual Stigma Scale (NMSS) 10. Sleep measured by the sleep related impairment scale 11. Health seeking behaviour measured by use of painkillers and health facility visits 12. Overall wellbeing measured by WHOQoL 13. Menstrual restrictions practiced measured by questions about whether girls avoid doing 14 different activities during their menstrual period, with an additional question to report restrictions not otherwise listed. The following outcomes are measured for caregivers and collected via in-person enumerator administered questionnaire: 14. Menstrual stigma measured using the Nepali Menstrual Stigma Scale (NMSS) 15. Adult responses to girls’ menstrual pain using the Adult Response to Children’s Symptoms (ARCS) adult report version 16. Beliefs about menstrual pain using the Pain Beliefs Questionnaire (PBQ)
Overall study start date	01/01/2023
Completion date	31/10/2027

Eligibility

Participant type(s)	Resident
Age group	Mixed
Lower age limit	13 Years
Upper age limit	18 Years
Sex	Female
Target number of participants	1920 girls, 48 clusters with 40 participants per cluster
Total final enrolment	1920
Key inclusion criteria	For the adolescents, the inclusion criteria are: 1. Female aged 13 to 18 years old. We will include stakeholders which includes mothers/mother in laws/female caregivers, fathers, community leaders, religious leaders, school teachers/nurses, healthcare providers in the community. The inclusion criteria are: 1. Caregiver of girl enrolled in trial
Key exclusion criteria	1. Unable to provide informed consent/assent
Date of first enrolment	14/12/2024
Date of final enrolment	20/01/2025

Locations

Countries of recruitment

Nepal

Study participating centres

Kopila Nepal

PO Box 287, Bulaundi-6, Pokhara, Gandaki Province
Pokhara
33411
Nepal

YGGP

Birendranagar-8, Surkhet, Karnali
Birendranagar
N/A
Nepal

Sponsor information

University of Bath
University/education

Claverton Down
Bath
BA2 7AY
England
United Kingdom

Phone	+44 (0)1225 388388
Email	hss-dc-support@bath.ac.uk
Website	http://www.bath.ac.uk/
"ROR"	https://ror.org/002h8g185

Funders

Funder type

Government

UK Research and Innovation
Government organisation / National government

Alternative name(s): UKRI
Location: United Kingdom

Results and Publications

Intention to publish date	01/12/2027
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in peer-reviewed journals, to share baseline, post-intervention results, and final 1-year follow up results.
IPD sharing plan	The anonymised quantitative survey data from the three rounds of data collection will be made available, but the details will be made available at a later date.

Editorial Notes

11/06/2025: Trial's existence confirmed by Nepal Health Research Council.