The Effect of Stress Ball on Recovery Quality and Hospital Discharge

October 9, 2024 updated by: Seval Ulubay

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

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 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 (Actual)

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.
90

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 Locations

  • Turkey
    • Atakum/Samsun
      • Samsun, Atakum/Samsun, Turkey, 55200
        • Seval Ulubay

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Patients under 18 years of age. Patients with communication problems.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Stress Ball Impact on Post-Transurethral Resection Recovery.
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.
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 applied after surgery on patients' recovery quality will be evaluated.
Other Names:
  • To examine the effects of the stress ball after surgery.
Experimental: The effect of the stress ball on patients' discharge time.
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
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 applied after surgery on patients' recovery quality will be evaluated.
Other Names:
  • To examine the effects of the stress ball after surgery.

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
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
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The effect of the stress ball applied after surgery on patients' discharge time will be evaluated.
Time Frame: 10 weeks
The primary outcome measure will be the difference in discharge times between patients who used stress balls post-surgery and those who did not.
10 weeks

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.
Seval Ulubay

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVAL ULUBAY, PHD, Samsun Gazi State Hospital

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 (Actual)

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.
March 1, 2024

Primary Completion (Actual)

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.
June 1, 2024

Study Completion (Actual)

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.
August 30, 2024

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).
October 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.
October 9, 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.
October 10, 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.
October 10, 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.
October 9, 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.
October 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.
  • TUR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

24 WEEKS

IPD Sharing Access Criteria

The access criteria for this study on stress ball application post-TURP establish clear inclusion and exclusion guidelines. Eligible participants are adult males aged 50 and older with benign prostatic hyperplasia (BPH) who can provide informed consent. Exclusion criteria include prior prostate surgeries, severe comorbidities, cognitive impairments, and allergies to stress ball materials. Data access is limited to the research team and the Clinical Ethics Committee to ensure ethical oversight and confidentiality through data anonymization. Participants may withdraw at any time without penalty. Collected data will be securely stored, with compliance monitored to uphold ethical standards and protect patient confidentiality during the evaluation of the stress ball application's effectiveness.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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