Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers

November 26, 2025 updated by: Derya Gezer, Cukurova University

Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers: A Randomized Controlled Trial

Diabetes mellitus (DM) is a common metabolic disease characterized by hyperglycemia, resulting from a deficiency or insufficiency of insulin. Diabetic foot ulcers (DFU), a late complication of diabetes, develop as a result of peripheral neuropathy, peripheral arterial disease, and trauma, negatively impacting individuals' quality of life and increasing the rate of hospitalization and amputation. While sharp debridement, one of the most effective methods in the management of diabetic foot ulcers, accelerates healing, it often causes pain and anxiety, which negatively impacts the treatment process. The physiological effects of anxiety include increased respiratory and heart rates, increased blood pressure, and prolonged procedure times. These effects can reduce patient compliance and complicate nursing care.

Non-pharmacological interventions offer important alternatives for pain and anxiety management. One such method, the use of a stress ball, is based on a distraction technique and is used to reduce individuals' emotional and physiological stress levels. The literature has demonstrated the positive effects of stress balls during endoscopy, biopsy, and skin procedures. However, there is insufficient evidence regarding the use of stress balls during sharp debridement. Therefore, this study aimed to evaluate the effects of stress balls on pain, distress, and physiological parameters during surgical debridement in patients with diabetic foot ulcers. The results of this study are expected to contribute to nursing care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Tarsus
      • Mersin, Tarsus, Turkey (Türkiye), 33400
        • Recruiting
        • Tarsus University
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who agree to participate in the study and sign the Informed Consent
  • Form will be included in the study.
  • They are over 18 years of age,
  • They are literate in Turkish,
  • They are undergoing surgical debridement for the first time,
  • They are receiving inpatient treatment in the ward, and
  • They have pain ≥1 on the Visual Analog Scale (VAS) before the procedure.

Exclusion Criteria:

  • Patients who have a diagnosed psychiatric or mental illness,
  • Regular painkiller use and chronic pain,
  • Visual, hearing, perception, or communication problems,
  • Physically impaired (such as an open wound on the hand or lack of muscle strength to squeeze a stress ball),
  • Decided to undergo an intervention to reduce pain before debridement (such as local anesthesia, nerve blockade, opioid analgesics, etc.),
  • Used non-pharmacological methods to reduce pain before the procedure will not be included in the study.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Routine care
Experimental: Stress ball
The effects of stress balls on pain, distress and physiological parameters during surgical debridement in patients with diabetic foot ulcers will be investigated.
Behavioral: Stress ball
The effects of stress balls on pain, distress and physiological parameters during surgical debridement in patients with diabetic foot ulcers will be investigated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Visual Analogue Scale -VAS: The scale was developed by Price and colleagues in 1983 for use in assessing subjectively perceived pain. Eti-Aslan noted in his study that the VAS is more sensitive and better defined in assessing acute pain. It is a 10 cm (100 mm) ruler with the word "painlessness" written on one end and "the most severe pain" written on the other. Participants were asked to indicate the intensity of pain they were currently experiencing, explaining that "0" on the scale means "I feel no pain" and that increasing numbers indicate increased pain intensity. "10" means "I feel the most severe pain." A higher score on the scale indicates increased pain.
Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Anxiety Assesment (The Distress Thermometer)
Time Frame: Before the Procedure and baseline, after an average of 20-30 minutes
The Distress Thermometer was first developed by Roth and colleagues for use in identifying non-pathological distress in patients undergoing cancer treatment after answering the necessary questions. The distress level is rated from 0 to 10. The practitioner expresses the distress experienced using the numbers on the thermometer. A score of zero indicates no distress, while a score of 10 indicates the highest level of distress. The green zone encompasses scores from 0 to 3. Individuals experiencing distress within this range are capable of managing their distress. The yellow zone encompasses scores from 4 to 6. A distress score in this range indicates that the individual is unable to manage their distress and requires intervention to return them to the green zone. The red zone encompasses scores from 7 to 10. Individuals experiencing distress within this range require urgent and comprehensive intervention.
Before the Procedure and baseline, after an average of 20-30 minutes
Physiological Parameters (heart rate, systolic and diastolic blood pressure, oxygen saturation and respiratory rate)
Time Frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate will be recorded before, during, and after debridement. Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor, while oxygen saturation and heart rate will be measured using the Masimo SET® Pulse Oximetry. Both devices will be calibrated before data collection.
Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameter: heart rate
Time Frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Heart rate will be measured using the Masimo SET® Pulse Oximetry. Devices will be calibrated before data collection.
Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameters: systolic and diastolic blood pressure
Time Frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor
Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameter: oxygen saturation
Time Frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Oxygen saturation will be measured using the Masimo SET® Pulse Oximetry. Device will be calibrated before data collection.
Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameter: respiratory rate
Time Frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Respiratory rate will be monitored for one minute, with each inspiration and expiration counted as a breath.
Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meggitt-Wagner classification
Time Frame: in recruitment

Meggitt-Wagner Classification of Diabetic Foot:

The Meggitt-Wagner classification was developed by Meggitt in 1976 and revised by Wagner in 1981. This classification system, which grades the wound into six categories from stage 0 to stage 5 based on the depth of the wound and the presence of osteomyelitis and gangrene, is evaluated based on observational findings, excluding ulcer depth. Findings of ischemia and infection are limited and do not include the presence of neuropathy. However, evaluation of these factors is known to have a positive impact on the healing process of diabetic foot ulcers.
in recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Chair: DERYA GEZER, Asisstant Professor, Tarsus University
  • Study Director: EZGİ MUTLUAY YAYLA, Asisstant Professor, Tarsus University
  • Study Director: DUDU ALPTEKİN, Dr, Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 28, 2025

First Submitted That Met QC Criteria

August 8, 2025

First Posted (Actual)

August 13, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stress Ball

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results regarding the effects of stress ball use on pain, anxiety, and hemodynamic parameters surgical debridement in individuals with diabetic foot ulcers will be shared. However, your personal information will not be shared.

IPD Sharing Supporting Information Type

  • CSR

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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