NCT06699563

Brief Summary

The purpose of this clinical study is to evaluate the effect of using motivational cards on pain and step counts in patients who underwent open prostate surgery due to benign prostatic hyperplasia.The main hypotheses are: H1: Patients who use motivation cards during mobilization after open prostate surgery have lower pain levels than those who do not. H2: Patients who used motivation cards for mobilization after open prostate surgery had a higher number of steps than those who did not use them. After the surgery, patients were asked to walk with a pedometer. A mobilization motivation card was used in the study group.

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 Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

November 19, 2024

Last Update Submit

July 31, 2025

Conditions

Keywords

WalkingPainMotivation

Outcome Measures

Primary Outcomes (1)

  • Number of steps after surgery

    Before mobilization, the number of steps taken will be tracked via a pedometer placed on the patient's waist, and after mobilization, the pedometer will be taken back from the patient. The number of steps taken will be recorded by the nurse.

    12 months

Secondary Outcomes (1)

  • Pain before and after mobilization

    12 months

Study Arms (2)

Experimental: Experimental (with Card)

EXPERIMENTAL

In this procedure, patients used a pedometer and mobilization motivation card during their mobilization on the first postoperative day.

Behavioral: Mobilization Motivation Card

No Intervention: Standard (No Card)

NO INTERVENTION

In this procedure, patients used a pedometer during their mobilization on the first postoperative day. They did not use a mobilization motivation card.

Interventions

On the morning of the surgery, the Mobilization Motivation Card and Pedometer will be introduced and the patient will be informed. On the morning of the first postoperative day, before the patient's first mobilization, pain assessment will be made with the Visual Analog Scale (VAS), and the Mobilization Motivation Card will be hung at the bedside during the day and will help increase the patient's participation in mobilization. Later, after a pedometer is attached to the patient's waist, the patient will be mobilized.

Experimental: Experimental (with Card)

Eligibility Criteria

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

You may qualify if:

  • Hospitalized in the ENT-Urology Clinic
  • Those aged 18 and over
  • Those who will undergo elective surgery
  • Volunteer to participate in the study
  • Post-surgical follow-up will be done in the service.
  • Those who will undergo general anesthesia
  • No mental problems
  • Patients who had no vision, hearing or speech problems were included.

You may not qualify if:

  • Those who will undergo emergency and unplanned surgical intervention
  • Laparoscopic surgery was performed
  • Taken to the intensive care unit after surgery
  • Those who will not undergo general anesthesia
  • Having mental problems
  • Patients with vision, hearing and speech problems were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Dr. İsmail Fehmi Cumalıoğlu City Hospital

Tekirdağ, Tekirdağ, 59000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic HyperplasiaPain

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seher Unver

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The data analyse is going to be completed by a independent researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 21, 2024

Study Start

January 29, 2024

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations