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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • İ̇zmi̇t
      • Kocaeli, İ̇zmi̇t, Turkey, 41100
        • Kocaeli University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Meditation
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their spiritual well-being level.
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.)
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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