NCT06635512

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 7, 2024

Last Update Submit

October 9, 2024

Conditions

Stress

Keywords

stress ballRecovery qualityhospital dischargethe effect of stress ball

Outcome Measures

Primary Outcomes (1)

  • 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

    10 weeks

Secondary Outcomes (1)

  • The effect of the stress ball applied after surgery on patients' discharge time will be evaluated.

    10 weeks

Study Arms (2)

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.

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

Other: The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge Time

Interventions

The Effect of Stress Ball Application After Transurethral Resection of the Prostate on Patients' Recovery Quality and Hospital Discharge TimeOTHER

The effect of the stress ball applied after surgery on patients' recovery quality will be evaluated.

Also known as: To examine the effects of the stress ball after surgery.
Stress Ball Impact on Post-Transurethral Resection Recovery.The effect of the stress ball on patients' discharge time.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seval Ulubay

Samsun, Atakum/Samsun, 55200, Turkey (Türkiye)

Location

Study Officials

  • Seval ULUBAY, PHD

    Samsun Gazi State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 10, 2024

Study Start

March 1, 2024

Primary Completion

June 1, 2024

Study Completion

August 30, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
24 WEEKS
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.

Locations

TU(1)