Plain English Summary
Background and study aims
The COVID-19 pandemic has had a particular impact on stress and satisfaction with life in women as they are subject to more demands and pressure in society. Since time immemorial, meditation has been accepted as a tool to help deal reduce stress and improve wellbeing. The motto of the Satyam Group of Institutions is ‘empowering women through education’ which resonates by developing preparedness through professional education, life skills and instilling the values of personal improvement. This study seeks to investigate whether Heartfulness meditation has an impact on satisfaction with life and perceived stress on the students of Satyam Group of Institutions. The intervention chosen for this project is a 12-week online Science of Meditation (SOM) program, with guidance from a Heartfulness meditation trainer coupled with structured education modules. Heartfulness is a simple heart-based meditation system aimed at attaining a balanced state of existence. The uniqueness of the Heartfulness system of meditation is an aspect called transmission which enhances the experience and effects of meditation. This will be explained during the sessions and the participants will be encouraged to experience the effects of transmission. Satisfaction with life is an important factor that can be adversely affected by stress. The aim of this study is to assess the effectiveness of Heartfulness meditation on alleviating stress and improving satisfaction with life among female students.
Who can participate?
Female students aged 18 years and over at the Satyam Group of Institutions
What does the study involve?
The online intervention based on the Heartfulness meditation system is composed of three main components. The live online meditation session is organized on a weekly basis for 12 weeks. The sessions are composed of 4 minutes of micro-meditation practice, a 15-minute presentation on the science of meditation, 24 minutes of guided meditation practice, 2 minutes of journaling and 15 minutes for questions and answers to help participants better understand the practice of meditation. The participants are requested to follow a 12-week self-paced online course. One module will be accessible each week. Participants will follow the pre-recorded content to review, integrate and go deeper into the understanding of the content and practice Heartfulness micro and core practices. The composition of each module is about 15 minutes of content, 24 minutes of one Heartfulness core practice, 2 to 6 minutes of micro-practice and journaling, and 15 minutes of homework. Participants are requested to practice daily the Heartfulness core practices (meditation, rejuvenation and inner connection) in the following schedule for 12 weeks: 15-20 minutes of Heartfulness meditation in the morning, 15-20 minutes of Heartfulness cleaning in the evening, and 5-10 minutes of Heartfulness inner connection before sleeping.
What are the possible benefits and risks of participating?
Participants may have a decrease in stress levels and increased satisfaction with life. In the practice of meditation, although calmness is induced, there can also be the experience of unwanted emotions and thoughts arising and passing. If the participant is unable to continue meditation due to this, they may open their eyes briefly, take a slow deep breath and then close their eyes to continue to meditate, or alternatively they may leave if that is their desire. There may also be bodily discomfort through sitting for a prolonged period. To address this, participants may change their posture to continue meditation. The recognition of this is part of the long-term benefit of the course, but it can be upsetting or uncomfortable in the short term. Participants have their first experience of the technique in the supportive atmosphere of the session and are taught what to expect and how to cope with experience as it unfolds.
They also have contact information from the trainer and participants may call or e-mail the trainer with any questions or concerns. If any experience in class reveals intent to self-harm, the investigators will follow up promptly. Participants often share their experiences in the group setting; therefore, the issue of confidentiality applies not just to trainers, but to group members as well. Participants will need to hold class events confidentially and will not give each other advice.
Where is the study run from?
Satyam Group of Institutions (India)
When is the study starting and how long is it expected to run for?
October 2021 to April 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Jayaram Thimmapuram
jthimmapuram@wellspan.org
Study website
Contact information
Type
Scientific
Contact name
Dr Jayaram Thimmapuram
ORCID ID
http://orcid.org/0000-0002-3189-3863
Contact details
2780 Meadow Cross Way
York
17402
United States of America
+1 (0)7174956027
jthimmapuram@wellspan.org
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
0508/Research/SGI-HFN
Study information
Scientific title
Effect of heartfulness meditation on perceived stress and satisfaction with life of students: a randomized waitlist controlled study
Acronym
Study hypothesis
1. Heartfulness meditation practice will be associated with a reduction in perceived stress in students after the meditation program.
2. Heartfulness meditation practice will be associated with improved satisfaction with life after the meditation program.
Ethics approval(s)
Approved 13/12/2021, Sathyam Ethics Committee (C-56 /14 &15, Sector 62 Noida-201309, (U.P.), India; +91 (0)9891081110; vandana.jaglan@satyamfashion.ac.in), ref: 0508/Research/SGI-HFN
Study design
Single-centre prospective randomized waitlist controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
School
Study type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Stress and satisfaction with life in students
Intervention
Computer randomization is performed.
The interventional group undergoes 12 weeks of Heartfulness meditation practice with measurement of Perceived Stress Scale scores and Satisfaction with Life Scale scores at week 0, 6, 12 and 18, respectively.
The control group undergoes 12 weeks of Heartfulness meditation practice starting at week 6 of the study with measurement of Perceived Stress Scale scores and Satisfaction with Life Scale scores at week 0, 6, 12 and 18, respectively.
Intervention type
Behavioural
Primary outcome measure
Stress measured using the Perceived Stress Scale (PSS) at baseline, week 6, week 12 and week 18
Secondary outcome measures
Satisfaction with life measured using the Satisfaction with Life Scale (SWLS) at baseline, week 6, week 12 and week 18
Overall study start date
01/10/2021
Overall study end date
25/04/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years and above
2. Willing to participate in the study
3. Female students of Satyam Group Institutions
Participant type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
240
Total final enrolment
212
Participant exclusion criteria
1. Inability to sit for 30-45 minutes
2. Unwilling to participate
Recruitment start date
13/12/2021
Recruitment end date
19/12/2021
Locations
Countries of recruitment
India
Study participating centre
Satyam Group of Insititutions
C-56 A/14 & 15, Sector 62
Noida
201309
India
Sponsor information
Organisation
Satyam Group of Institutions
Sponsor details
c-56 A/14 &15
Sector 62
Noida
201309
India
+91 (0)9891081110, +91 (0)120 4242805, +91 (0)120 4540130
vandana.jaglan@satyamfashion.ac.in
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
01/01/2023
Individual participant data (IPD) sharing plan
De-identified data may be available with the research board. An Excel sheet with information about the collected scores of the participant will be with the research board. Informed consent was obtained from participants for the study.
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/11/2023 | 01/12/2023 | Yes | No |