StressNCT06635512
The Effect of Stress Ball on Recovery Quality and Hospital Discharge
A study testing The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time in people with Stress, run by Seval Ulubay at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of stress ball application after transurethral resection of the prostate on patients' recovery quality and hospital discharge time. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Aug 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Will be applied to patients who are over 18 years old. Have no hearing or vision problems. Can read and write, and can communicate effectively.
Who cannot join
- Patients under 18 years of age. Patients with communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time: A Randomized Controlled Study
This study aims to investigate the effect of stress ball application after transurethral resection of the prostate on patients' recovery quality and hospital discharge time.
Read the detailed description
The stress ball, one of the distraction methods, is an effective technique for ensuring cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. Squeezing a stress ball during a surgical procedure allows patients to have direct control over the object, enhancing their feelings of empowerment. In this way, it positively impacts anxiety and patient satisfaction without interfering with the surgical process. In the study by Yanes et al., the effects of the stress ball and hand-holding on pain, anxiety, and satisfaction were evaluated during skin cancer surgery performed under local anesthesia. Although anxiety was observed to decrease in all groups, no significant difference was found between the groups regarding pain and anxiety. It was noted that nearly all participants were very satisfied. The use of the stress ball appears to help reduce anxiety in anxious patients prior to the procedure. In a study conducted by Kasar et al. on hemodialysis patients, the effects of stress ball usage on stress, vital signs, and comfort levels were investigated. While the use of the stress ball did not affect vital signs and comfort, it demonstrated a positive impact on stress. In a study investigating the effects of distraction methods used during cystoscopy on pain, anxiety, and satisfaction, it was found that anxiety levels post-procedure were lower in the intervention groups (music, video, and stress ball) compared to the control group, while satisfaction levels were higher . Another randomized controlled study evaluated the effectiveness of three different non-pharmacological methods (coughing technique, spirometer blowing, and squeezing a stress ball) in reducing pain during intravenous catheterization. It was reported that the average pain levels in the coughing, spirometer, and stress ball groups were lower compared to the control group . In a study examining the effectiveness of distraction methods for pain and anxiety management during invasive venous surgical procedures, it was indicated that pain and anxiety levels were significantly lower in the interaction with nurses and stress ball group . In a study on managing dental anxiety with the application of a stress ball, no significant difference was found between the anxiety scores of patients who used the stress ball and those who did not. Similarly, in another study investigating the effects of distraction methods during lithotripsy, no significant difference was observed in pain and anxiety scores between the control and intervention groups (music and stress ball) .
- Conditions
- Stress
- Being tested
- The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time
- Keywords
- stress ball, Recovery quality, hospital discharge, the effect of stress ball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge TimeOther
Also called To examine the effects of the stress ball after surgery.
The effect of the stress ball applied after surgery on patients' recovery quality will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Impact on Post-Transurethral Resection Recovery. | Experimental | Participants will use stress balls regularly, and outcomes such as physical strength, pain levels, and psychological well-being will be assessed to evaluate the intervention's impact. Receives: Other: The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time |
| The effect of the stress ball on patients' discharge time. | Experimental | This arm of the study examines how the use of stress balls during recovery affects the length of hospital stay and discharge time for patients Receives: Other: The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the method used on post-surgery recovery quality
The primary outcome measure for this study will be the overall quality of post-surgery recovery, assessed through standardized questionnaires evaluating functional mobility, and patient satisfaction
Measured: 10 weeks
Secondary outcomes (1)
The effect of the stress ball applied after surgery on patients' discharge time will be evaluated.
The primary outcome measure will be the difference in discharge times between patients who used stress balls post-surgery and those who did not.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seval Ulubay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seval Ulubay, Istanbul University - Cerrahpasa
- Investigators
- Seval ULUBAY, PHD, Principal investigator, Gazi State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635512
- Sponsor's protocol ID
- TUR
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This IPD Sharing Plan investigates the impact of stress ball application on recovery quality and hospital discharge time after transurethral resection of the prostate (TURP). Conducted by the Department of Urology at a University Hospital, it involves researchers, data analysts, and patients in intervention and control groups. The plan outlines clear roles, promotes collaboration, and ensures equitable sharing of findings. Weekly meetings and regular reports will facilitate communication, while performance metrics will assess recovery outcomes. Ongoing training will enhance ethical standards and data collection, aiming to optimize patient recovery through transparent stakeholder collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06635512
- Acronym / sponsor ID
- TUR
- Conditions
- Stress
- Keywords
- stress ball, Recovery quality, hospital discharge, the effect of stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seval UlubayUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 10 Oct 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 study aims to investigate the effect of stress ball application after transurethral resection of the prostate on patients' recovery quality and hospital discharge time.
Detailed description
The stress ball, one of the distraction methods, is an effective technique for ensuring cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. Squeezing a stress ball during a surgical procedure allows patients to have direct control over the object, enhancing their feelings of empowerment. In this way, it positively impacts anxiety and patient satisfaction without interfering with the surgical process. In the study by Yanes et al., the effects of the stress ball and hand-holding on pain, anxiety, and satisfaction were evaluated during skin cancer surgery performed under local anesthesia. Although anxiety was observed to decrease in all groups, no significant difference was found between the groups regarding pain and anxiety. It was noted that nearly all participants were very satisfied. The use of the stress ball appears to help reduce anxiety in anxious patients prior to the procedure. In a study conducted by Kasar et al. on hemodialysis patients, the effects of stress ball usage on stress, vital signs, and comfort levels were investigated. While the use of the stress ball did not affect vital signs and comfort, it demonstrated a positive impact on stress. In a study investigating the effects of distraction methods used during cystoscopy on pain, anxiety, and satisfaction, it was found that anxiety levels post-procedure were lower in the intervention groups (music, video, and stress ball) compared to the control group, while satisfaction levels were higher . Another randomized controlled study evaluated the effectiveness of three different non-pharmacological methods (coughing technique, spirometer blowing, and squeezing a stress ball) in reducing pain during intravenous catheterization. It was reported that the average pain levels in the coughing, spirometer, and stress ball groups were lower compared to the control group . In a study examining the effectiveness of distraction methods for pain and anxiety management during invasive venous surgical procedures, it was indicated that pain and anxiety levels were significantly lower in the interaction with nurses and stress ball group . In a study on managing dental anxiety with the application of a stress ball, no significant difference was found between the anxiety scores of patients who used the stress ball and those who did not. Similarly, in another study investigating the effects of distraction methods during lithotripsy, no significant difference was observed in pain and anxiety scores between the control and intervention groups (music and stress ball) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Impact on Post-Transurethral Resection Recovery. | Experimental | Other: The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge TimeParticipants will use stress balls regularly, and outcomes such as physical strength, pain levels, and psychological well-being will be assessed to evaluate the intervention's impact. |
| The effect of the stress ball on patients' discharge time. | Experimental | Other: The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge TimeThis arm of the study examines how the use of stress balls during recovery affects the length of hospital stay and discharge time for patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Will be applied to patients who are over 18 years old. Have no hearing or vision problems. Can read and write, and can communicate effectively.
Key exclusion criteria (1 listed)
- Patients under 18 years of age. Patients with communication problems.
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 |
|---|---|---|
| The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge TimeAlso: To examine the effects of the stress ball after surgery.The effect of the stress ball applied after surgery on patients' recovery quality will be evaluated. | Other | Stress Ball Impact on Post-Transurethral Resection Recovery., The effect of the stress ball on patients' discharge time. |
Primary outcome
The effect of the method used on post-surgery recovery quality
Time frame: 10 weeks
The primary outcome measure for this study will be the overall quality of post-surgery recovery, assessed through standardized questionnaires evaluating functional mobility, and patient satisfaction
1 secondary outcome
The effect of the stress ball applied after surgery on patients' discharge time will be evaluated.
Time frame: 10 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 10 Oct 2024.
- Individual participant dataSharing planned: Yes. This IPD Sharing Plan investigates the impact of stress ball application on recovery quality and hospital discharge time after transurethral resection of the prostate (TURP). Conducted by the Department of Urology at a University Hospital, it involves researchers, data analysts, and patients in intervention and control groups. The plan outlines clear roles, promotes collaboration, and ensures equitable sharing of findings. Weekly meetings and regular reports will facilitate communication, while performance metrics will assess recovery outcomes. Ongoing training will enhance ethical standards and data collection, aiming to optimize patient recovery through transparent stakeholder collaboration.
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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.
Seval ULUBAY, PHD principal investigator
Gazi State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time in people with Stress, run by Seval Ulubay 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 1 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 10 Oct 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?
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?
The effect of the method used on post-surgery recovery quality (time frame: 10 weeks). 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 10 Oct 2024.