Caregivers With a Child Followed up With a Cancer DiagnosisNCT05807295
The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.
A study testing Relaxation Program in people with Caregivers With a Child Followed up With a Cancer Diagnosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers With a Child Followed up With a Cancer Diagnosis
- What is being tested?
- Relaxation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2023to 1 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The child has received cancer treatment for at least two months,
- Those who have internet access on their smartphone or computer
- Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)
Who cannot join
- Those whose children/caregivers are in the terminal period,
- Those whose child/caregiver has not received chemotherapy treatment,
- Those who take medication for anxiety or use one of the complementary medicine approaches.
Trial locations and contacts
1 site in 1 country.
About this study
This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks
Read the detailed description
In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.
- Being tested
- Relaxation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation ProgramOther
Also called The relaxation program for caregivers
The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Videos will be sent to caregivers' social media accounts. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | caregivers receiving a relaxation program Receives: Other: Relaxation Program |
| Control group | No intervention | the group that did not receive any training |
What is being measured
The primary outcome is the main question the study is designed to answer.
coping with stress
The scale is a 23-item self-report measure of anxiety using a 5-point Likert-type scale. The scale does not have a cut-off point. The higher the score obtained from the scale, the better the coping is determined.
Measured: Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)
Anxiety
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Measured: Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start13 Apr 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion1 Aug 2023 (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 Caregivers With a Child Followed up With a Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Sarı Öztürk, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807295
- Sponsor's protocol ID
- 1503
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozturk CS, Katikol E. Effect of mHealth-based relaxation program on stress coping and anxiety levels in mothers of children with cancer: A randomized controlled study. Patient Educ Couns. 2024 Jun;123:108247. doi: 10.1016/j.pec.2024.108247. Epub 2024 Mar 11.
PubMed 38471311
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.
- ClinicalTrials.gov ID
- NCT05807295
- Acronym / sponsor ID
- 1503
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 13 Apr 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 11 Apr 2023 (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.
This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks
Detailed description
In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Relaxation Programcaregivers receiving a relaxation program |
| Control group | No intervention | –the group that did not receive any training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The child has received cancer treatment for at least two months,
- Those who have internet access on their smartphone or computer
- Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)
Key exclusion criteria (3 listed)
- Those whose children/caregivers are in the terminal period,
- Those whose child/caregiver has not received chemotherapy treatment,
- Those who take medication for anxiety or use one of the complementary medicine approaches.
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 |
|---|---|---|
| Relaxation ProgramAlso: The relaxation program for caregiversThe relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Videos will be sent to caregivers' social media accounts. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. | Other | Intervention |
Primary outcome
coping with stress
Time frame: Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)
The scale is a 23-item self-report measure of anxiety using a 5-point Likert-type scale. The scale does not have a cut-off point. The higher the score obtained from the scale, the better the coping is determined.
Anxiety
Time frame: Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 38471311Ozturk CS, Katikol E. Effect of mHealth-based relaxation program on stress coping and anxiety levels in mothers of children with cancer: A randomized controlled study. Patient Educ Couns. 2024 Jun;123:108247. doi: 10.1016/j.pec.2024.108247. Epub 2024 Mar 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Program in people with Caregivers With a Child Followed up With a Cancer Diagnosis, run by Gazi 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 3 inclusion and 3 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 11 Apr 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coping with stress (time frame: Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)). 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 NCT05807295, 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 11 Apr 2023.