Patients With Breast CancerNCT06460974
The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer
A study testing stress ball in people with Patients With Breast Cancer, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Patients With Breast Cancer
- What is being tested?
- stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2024to Dec 2024
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who is literate in Turkish,
- who was diagnosed with stage 1, 2 and 3 breast cancer
- who had the second cure or above chemotherapy receiving treatment
- over 18 years of age
- female
- platelet level >50,000 mm3
- not having any physical problems squeezing a stress ball
Who cannot join
- those who did not agree to participate in the study
- those who received chemotherapy for the first time,
- those who had any physical disability to squeeze a stress ball
- Any receiving intravenous treatment from both arms,
- having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
- having any psychiatric disease,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University
Mersin, 33110
Birgül VURAL DOĞRU, Associate Prof., 03243610001, bvuraldogru@gmail.com
Hatice ŞİMŞEK, PhD student
About this study
Official title: The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer: A Randomized Controlled Study
This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.
Read the detailed description
The research was conducted as a randomized controlled study. A total of 74 patients were randomly assigned to the stress ball group (n=37) and the control group (n=37).
- Conditions
- Patients With Breast Cancer
- Being tested
- stress ball
- Keywords
- Anxiety, Comfort, Breast Cancer, Stress, Stress Ball
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballOther
A stress ball was applied to the patients in the during chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| stress ball group | Experimental | A stress ball was applied to the patients in the stress ball group during chemotherapy treatment Receives: Other: stress ball |
| Control group | No intervention | Standard care without any additional application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress Thermometer
Distress level is determined by a visual analog scale ranging from "0-10". Patients express the psychological distress they feel with the numbers on the thermometer; "0 points" means that the patient does not experience any distress, and "10 points" means that the patient experiences the highest level of distress
Measured: 6 months
State-Trait Anxiety Inventory
It evaluates the state of anxiety felt by the individual due to the stressful situation he is in. The first 20 items, consisting of short statements, measure the individual's state anxiety level.
Measured: 6 months
General Comfort Scale
The scale contains a total of 48 items in a four-point Likert type and consists of four sub-dimensions (physical, psycho-spiritual, environmental, and socio-cultural sub-dimensions).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Breast CancerStudies of the same condition, open and under way.
- More trials run by Mersin 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
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgul Vural Dogru, Mersin University
- Investigators
- Birgül VURAL DOĞRU, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460974
- Sponsor's protocol ID
- MU-HF-BVD-02
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06460974
- Acronym / sponsor ID
- MU-HF-BVD-02
- Conditions
- Patients With Breast Cancer
- Keywords
- Anxiety, Comfort, Breast Cancer, Stress, Stress Ball
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jun 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.
This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.
Detailed description
The research was conducted as a randomized controlled study. A total of 74 patients were randomly assigned to the stress ball group (n=37) and the control group (n=37).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stress ball group | Experimental | Other: stress ballA stress ball was applied to the patients in the stress ball group during chemotherapy treatment |
| Control group | No intervention | –Standard care without any additional application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- who is literate in Turkish,
- who was diagnosed with stage 1, 2 and 3 breast cancer
- who had the second cure or above chemotherapy receiving treatment
- over 18 years of age
- female
Key exclusion criteria (6 listed)
- those who did not agree to participate in the study
- those who received chemotherapy for the first time,
- those who had any physical disability to squeeze a stress ball
- Any receiving intravenous treatment from both arms,
- having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
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 |
|---|---|---|
| stress ballA stress ball was applied to the patients in the during chemotherapy treatment. | Other | stress ball group |
Primary outcome
Distress Thermometer
Time frame: 6 months
Distress level is determined by a visual analog scale ranging from "0-10". Patients express the psychological distress they feel with the numbers on the thermometer; "0 points" means that the patient does not experience any distress, and "10 points" means that the patient experiences the highest level of distress
State-Trait Anxiety Inventory
Time frame: 6 months
It evaluates the state of anxiety felt by the individual due to the stressful situation he is in. The first 20 items, consisting of short statements, measure the individual's state anxiety level.
General Comfort Scale
Time frame: 6 months
The scale contains a total of 48 items in a four-point Likert type and consists of four sub-dimensions (physical, psycho-spiritual, environmental, and socio-cultural sub-dimensions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Birgül VURAL DOĞRU principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball in people with Patients With Breast Cancer, run by Mersin 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 7 inclusion and 6 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 14 Jun 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 Birgül VURAL DOĞRU (03243610001, bvuraldogru@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress Thermometer (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.