Well-Being, PsychologicalNCT06484283
The Effect of Meditation on Resilience and Spiritual Well-Being Levels
A study testing Meditation in people with Well-Being, Psychological, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years, women only
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Well-Being, Psychological
- Being tested
- Meditation
- Keywords
- Oncology, Meditation, Resilience, Spiritual Well-Being
- Medical subject headings
- Psychological Well-Being, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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 Receives: Other: Meditation |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their spiritual well-being level.
Measured: Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.
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.)
The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their resilience level.
Measured: Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Simsek Sahin, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484283
- Sponsor's protocol ID
- E-45778635-050.99-144574
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to roll out IPD.
Publications
Erdogan B, Simsek Sahin E, Oz T. Empowering Mothers: The Effects of Audio-Guided Meditation on Resilience and Spiritual Well-Being of Mothers of Children Diagnosed with Cancer in Turkiye-A Randomized Controlled Trial. J Relig Health. 2026 Apr;65(2):2143-2162. doi: 10.1007/s10943-026-02601-w. Epub 2026 Mar 2.
PubMed 41772279
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06484283
- Acronym / sponsor ID
- E-45778635-050.99-144574
- Conditions
- Well-Being, Psychological
- Keywords
- Oncology, Meditation, Resilience, Spiritual Well-Being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: MeditationResearchers 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 |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationGuided 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. | Other | Experimental Group |
Primary outcome
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.
The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their spiritual well-being level.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 41772279Erdogan B, Simsek Sahin E, Oz T. Empowering Mothers: The Effects of Audio-Guided Meditation on Resilience and Spiritual Well-Being of Mothers of Children Diagnosed with Cancer in Turkiye-A Randomized Controlled Trial. J Relig Health. 2026 Apr;65(2):2143-2162. doi: 10.1007/s10943-026-02601-w. Epub 2026 Mar 2.
- Individual participant dataSharing planned: No. There are no plans to roll out IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Well-Being, Psychological, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eda SIMSEK SAHIN, M.Sc (05452788909, simsekeda24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.