Pain, AcuteNCT06131606
Effect of Stress Ball in Angiography
A study testing experimental group in people with Pain, Acute, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The target of this study was to determine the influence of stress ball application on pain and anxiety levels experienced by patients during angiography procedures. Read more about this study
- Who is it for?
- Ages 47 to 51 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2023to 15 Jul 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 47 to 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- no communication problems,
- being older than 18 years of age,
- having good mental health,
- undergoing wrist angiography (Radial Angiography),
- being willing to take part in the study.
Who cannot join
- Any complication during angiography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Stress Ball in Angiography: A Randomized Controlled Trial
The target of this study was to determine the influence of stress ball application on pain and anxiety levels experienced by patients during angiography procedures.
Read the detailed description
The purpose of this research was to investigate the effect of stress ball application, which is a non-pharmacologic method, on the pain and anxiety levels of patients during the angiography procedure. The present randomized controlled trial was conducted on all adult patients undergoing angiography between January 2023 and June 2023 in the Cardiovascular Surgery Clinic of a state hospital in eastern Turkey. The sample population was composed of 120 randomized patients who underwent stress ball application and received routine care. Numerical Rating Scale (NRS), Patient Information Form, and State-Trait Anxiety Inventory (STAI) were employed for data collection. The mean NRS posttest score of the experimental group patients increased significantly less than the control group (p<0.001), while the mean STAI posttest score decreased significantly (p= 0.019). A positive significant correlation was determined between the mean NRS and STAI post-test scores of the patients in the experimental group (p<0.05). It was found that the level of state-trait anxiety decreased as the pain decreased. The stress ball applied during angiography decreased the anxiety and pain levels of the patients. Stress ball application may be recommended as a complementary method to support pharmacologic treatment.
- Conditions
- Pain, Acute
- Being tested
- experimental group
- Keywords
- Pain, Angiography, Anxiety, Nursing, Stress ball
- Medical subject headings
- Acute Pain, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupBehavioural
Patients in the experimental group were told how to use the stress ball before the procedure. The patient was then taken to the angiography unit. The stress ball was placed on the palms of the patients according to the procedure position. During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes. After the procedure, the NRS and STAI were filled out as a post-test 10 minutes after the patient was taken to the ward. The answers given by the patients were recorded by the researcher by marking them on the forms.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes. Receives: Behavioral: experimental group |
| control group | No intervention | No intervention other than the clinic protocol was applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
This scale, which assesses the degree of pain, aims to make the patient express their pain in numbers. It starts with no pain (0) and goes up to unbearable pain (10 or 100). The high level of pain reporting is known as a disadvantage. Miró et al. found that the validity of the NRS for pain assessment was at an acceptable level (Miró et al., 2009). Hjermstad et al. compared the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), and Verbal Descriptor Scale (VDS) for the assessment of pain intensity in adults and found that the NRS was more understandable and easier to use than the VAS and VDS
Measured: two weeks
Secondary outcomes (1)
State-Trait Anxiety Inventory (STAI)
The scale was developed by Spielberger et al. Its reliability and validity in our country were performed by Öner and Le Compte. The scale consists of two subunits that measure anxiety separately, but in this study, the state-trait anxiety that patients feel indirectly from the stressful situation they are in will be used. A scale of 4-point Likert-type consisting of 20-item short statements measures the state-trait anxiety level of the individual.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start10 Jan 2023
- Primary completion10 Jul 2023
- Study completion15 Jul 2023
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 Pain, AcuteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This controlled randomized study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Güneş, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131606
- Sponsor's protocol ID
- FU-SN-DG-01
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuksel D, Gunes D. The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial. Cardiovasc Ther. 2024 Aug 24;2024:5049092. doi: 10.1155/2024/5049092. eCollection 2024.
PubMed 39742013
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball in Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06131606
- Acronym / sponsor ID
- FU-SN-DG-01
- Conditions
- Pain, Acute
- Keywords
- Pain, Angiography, Anxiety, Nursing, Stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 14 Nov 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.
The target of this study was to determine the influence of stress ball application on pain and anxiety levels experienced by patients during angiography procedures.
Detailed description
The purpose of this research was to investigate the effect of stress ball application, which is a non-pharmacologic method, on the pain and anxiety levels of patients during the angiography procedure. The present randomized controlled trial was conducted on all adult patients undergoing angiography between January 2023 and June 2023 in the Cardiovascular Surgery Clinic of a state hospital in eastern Turkey. The sample population was composed of 120 randomized patients who underwent stress ball application and received routine care. Numerical Rating Scale (NRS), Patient Information Form, and State-Trait Anxiety Inventory (STAI) were employed for data collection. The mean NRS posttest score of the experimental group patients increased significantly less than the control group (p<0.001), while the mean STAI posttest score decreased significantly (p= 0.019). A positive significant correlation was determined between the mean NRS and STAI post-test scores of the patients in the experimental group (p<0.05). It was found that the level of state-trait anxiety decreased as the pain decreased. The stress ball applied during angiography decreased the anxiety and pain levels of the patients. Stress ball application may be recommended as a complementary method to support pharmacologic treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This controlled randomized study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: experimental groupDuring the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes. |
| control group | No intervention | –No intervention other than the clinic protocol was applied to this group. |
Who may qualify
- Ages
- 47 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- no communication problems,
- being older than 18 years of age,
- having good mental health,
- undergoing wrist angiography (Radial Angiography),
- being willing to take part in the study.
Key exclusion criteria (1 listed)
- Any complication during angiography.
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 |
|---|---|---|
| experimental groupPatients in the experimental group were told how to use the stress ball before the procedure. The patient was then taken to the angiography unit. The stress ball was placed on the palms of the patients according to the procedure position. During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes. After the procedure, the NRS and STAI were filled out as a post-test 10 minutes after the patient was taken to the ward. The answers given by the patients were recorded by the researcher by marking them on the forms. | Behavioural | experimental group |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: two weeks
This scale, which assesses the degree of pain, aims to make the patient express their pain in numbers. It starts with no pain (0) and goes up to unbearable pain (10 or 100). The high level of pain reporting is known as a disadvantage. Miró et al. found that the validity of the NRS for pain assessment was at an acceptable level (Miró et al., 2009). Hjermstad et al. compared the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), and Verbal Descriptor Scale (VDS) for the assessment of pain intensity in adults and found that the NRS was more understandable and easier to use than the VAS and VDS
1 secondary outcome
State-Trait Anxiety Inventory (STAI)
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39742013Yuksel D, Gunes D. The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial. Cardiovasc Ther. 2024 Aug 24;2024:5049092. doi: 10.1155/2024/5049092. eCollection 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.
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 experimental group in people with Pain, Acute, run by Firat 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 14 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical Rating Scale (NRS) (time frame: two weeks). 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 NCT06131606, 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 14 Nov 2023.