- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484283
The Effect of Meditation on Resilience and Spiritual Well-Being Levels
June 25, 2024 updated by: Eda Simsek Sahin, Kocaeli University
Investigation of the Effect of Meditation Applied to Mothers With Oncology-Diagnosed Children on Mothers' Resilience and Spiritual Well-Being Levels: A Randomized Controlled Study
Childhood cancers have become an important health problem with a rapidly increasing incidence.
Although global and national data show that the developmental status of countries has an impact on the success of treatment, there is a significant increase in the incidence of childhood cancers.
With the diagnosis of childhood cancer, long-term and exhausting treatments, increased financial and moral burdens and psycho-social difficulties affect children, but it is inevitable that the child's parents are also affected by the situation.
Childhood cancer has serious effects on the physical and psychological health of pediatric patients, their families and caregivers.
In this process, parents may face psychosocial problems such as depression, anxiety, stress, fatigue, burnout, disruption of family dynamics and inadequacy.
Although the treatment process affects the adaptation, coping and family dynamics of all family members, it can be much more tiring and exhausting for mothers, who are often the primary caregivers of the child.Studies point out that parents of a child with oncology need to adapt to the long and strenuous treatment procedures in order to cope and cope with these challenges.
Adaptation involves parents more quickly in integrating and taking an active role in the treatment and care processes.
This has been linked to people's ability to be resilient.
Although resilience is an ability that develops over time, it is very important to support the family of parents of children diagnosed with oncology in this sense.
Meditation is a practice with ancient teachings dating back at least 3000 years.
In recent years there has been a growing interest in its benefits for psychological and spiritual well-being in many fields including medicine, nursing, psychology, sociology and education.
Although it has a wide variety of definitions and contents, it generally consists of practices such as attention and focus training for mindfulness, breathing and relaxation practices for relaxation, and attention practices for mental calming.
Studies show that meditation practices are used for purposes such as individual and psychological well-being, anxiety, depression, strengthening spirituality and positive results are obtained.
This study aims to determine the effects of meditation on the spiritual well-being and resilience levels of mothers with oncologically diagnosed children aged 6-18 years.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Meditation is a practice that dates back at least 3000 years and has ancient teachings.
In recent years, there has been increasing interest in its benefits for psychological and spiritual well-being in many fields, including medicine, nursing, psychology, sociology, and education.
Although it has various definitions and contents, it generally consists of practices such as attention and focus training for awareness, breathing and relaxation practices for relaxation, and attention practices for mental calming.
Studies show that meditation practices are used for purposes such as individual and psychological well-being, anxiety, depression, and strengthening spirituality, and positive results are obtained.
It is the responsibility of nurses to protect and support parents from distressing and tiring processes such as having a child diagnosed with oncology, caring for the child, and interrupting family processes.
Nurses are among the most active participants in the process, working with parents and the child throughout the entire process, starting from the child's diagnosis.
Examining and evaluating parents' spiritual strength and resilience and intervening in time is very important.
This research was planned to investigate the spiritual well-being and resilience of mothers with children diagnosed with oncology and to determine and evaluate the effect of meditation practice on these parameters.
So, what can we do to empower parents of children diagnosed with oncology?
Plans to contribute to the literature on the subject.
Contributing to a particular field, such as pediatric oncology, will support nurses working in these units to develop a more comprehensive and holistic approach and improve their quality of care.
Quality care will positively support, strengthen and guide the child and the parents on this journey.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eda SIMSEK SAHIN, M.Sc
- Phone Number: 05452788909
- Email: simsekeda24@gmail.com
Study Contact Backup
- Name: Birgul ERDOGAN, M.Sc
- Phone Number: 05307980416
- Email: b.erdogan0816@outlook.com
Study Locations
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İ̇zmi̇t
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Kocaeli, İ̇zmi̇t, Turkey, 41100
- Kocaeli University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Mothers whose children have been diagnosed with oncology,
- Mothers whose children have received at least one course of chemotherapy
- Mothers who can speak and understand Turkish
- Mothers who volunteer to participate in the study will be included.
Exclusion Criteria:
- Mothers who have a particular problem that prevents communication (neurodevelopmental delay, verbal speech difficulty, hearing or hearing problems),
- Mothers who are being treated for relapse or whose children are in the terminal stage will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
Researchers will inform mothers who apply to the unit and invite them to participate in the study.
The informed consent form will be read to mothers who accept the study, and their written consent will be obtained.
A simple randomization method will be used to control selection bias that may arise while determining research groups.
All study participants (intervention and control groups) will be asked to complete the Introductory Characteristics Form, Spiritual Well-Being Scale, and Connor Davidson Resilience Scale Short Form.
After this stage, mothers in the intervention group will be given a meditation application video, and the details of the application (how long and how to meditate) will be explained.
After the implementation period, the mothers will be again administered the Spiritual Well-Being Scale and the Connor Davidson Resilience Scale Short Form
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Guided meditation will be applied within the scope of the study.
A guided meditation video prepared by a Yoga Alliance-certified researcher will be used for this intervention.
Guided meditation aims to ensure being in the moment (here and now) with the help of breathing.
Meditation practice will take participants 10 minutes.
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No Intervention: Control Group
No intervention will be made to the control group.
To act ethically, after data is collected from the experimental and control groups, participants in the control group will be given the meditation video to practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spiritual well-being level (measured by "Spiritual Well-being Scale".It is a five-point Likert scale comprising 29 items in three sub-dimensions. The score that can be obtained from the scale varies between 29 and 145.)
Time Frame: Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.
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The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their spiritual well-being level.
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Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.
|
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Resilience level (measured by the Connor Davidson Resilience Scale Short Form. The scores that can be obtained from the scale vary between 0 and 40. High scores obtained from the scale are considered as high psychological resilience.)
Time Frame: Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.
|
The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their resilience level.
|
Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
June 7, 2024
First Submitted That Met QC Criteria
June 25, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
June 25, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-45778635-050.99-144574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans to roll out IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.