Diabetic Foot UlcerNCT06316115
Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
A study testing In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement in people with Diabetic Foot Ulcer, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2023to 10 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- Being an inpatient in the endocrinology clinic,
- Volunteer,
- No communication problems (No hearing, understanding and speaking problems),
- Being a patient diagnosed with diabetic foot ulcer,
- The physician decided to apply sharp debridement,
- Having pain according to the Visual Comparison Scale before the sharp debridement procedure,
- Not having a health problem with the hand that would prevent him from using the ball
Who cannot join
- No pain according to the Visual Comparison Scale,
- Before performing sharp debridement, an intervention decision was taken to reduce pain (local anesthesia).
- administered, nerve blockade, opioid analgesics, etc.) excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran Universitesi
Sanliurfa
Fatma ASLAN, +905427760715, fatmaaslan62@gmail.com
About this study
Official title: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement.
Read the detailed description
The annual number of patients hospitalized with diabetic foot ulcer treatment is 543, and the sample calculation of the study was determined using the G*Power program. Since there was no previous study conducted in the same study group, a study examining the effect of stress ball on pain in invasive procedures was taken as reference in the calculation of the sample. In this study, it was predicted that the difference between pain intensities would be evaluated with a t test, and the effect value was predicted to be 0.70 with a 95% confidence interval and 80% power, and it was calculated that 34 participants would be sufficient for the sample. Considering possible losses from the study (hospitalization, death, changing treatment center, etc.), a total of 76 patients, 38 in each group, were aimed to be included in the study.
As a data collection tool; Introductory Information Form, Meggit-Wagner Classification, Visual Comparison Scale and State Anxiety Scale (STAI) will be used.
Intervention Group: Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure, and each patient will be debrided by the same person throughout the procedure. The patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure.
Control Group: The patient's pain and anxiety will be evaluated by a nurse independent of the research before and during the debridement procedure, without any intervention to the patients.
Stress ball use: Before starting the study, the researchers explained to the patients theoretically how to use the stress ball and demonstrated it practically. Then, the patient was asked to use the ball and it was confirmed whether he was using it correctly. Patients will be asked to count to three, squeeze the ball once and then relax it, inhale each time they squeeze the ball, and exhale when they relax it. The stress ball used is made of medium hardness and high quality silicone. The balls will be provided by the researchers and given to the patients. Patients will use the stress ball throughout the debridement procedure and will continue to use it until the procedure is completed. Statistical significance level will be accepted as p <0.05.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
- Keywords
- diabetic food ulcer, stress ball, pain, anxciety
- Medical subject headings
- Diabetic Foot, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp DebrıdementOther
Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure, and each patient will be debrided by the same person throughout the procedure. The patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure.
| Study group | Role | What they receive |
|---|---|---|
| Wound debridement of patients with diabetic foot ulcers | No intervention | No Intervention: The patient's pain and anxiety will be evaluated by a nurse independent of the research before and during the debridement procedure, without any intervention to the patients |
| Patients with diabetic foot ulcers using stress balls during wound debridement | Experimental | Intervention Group: Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure, and each patient will be debrided by the same person throughout the procedure. The patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure. Receives: Other: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
Introductory information formula section by examining studies conducted with products diagnosed with diabetic foot ulcers. Promotional information regime; People's birth year, education level, employment status, income level, place of residence, year of diabetes diagnosis, etc. A total of 13 questions will be asked about.
Measured: at enrollment
Secondary outcomes (1)
Meggit-Wagner classification of diabetic foot
This classification system, which is based on the depth of the wound and graded in six categories from stage 0 to stage 5 according to the presence of osteomyelitis and gangrene, is evaluated with observational findings, excluding the depth of injuries. There are no limits of ischemia and cryptocurrencies and there is no presence of neuropathy. However, the positive effects of considering this in the improvement process of diabetic foot killing are known. The classification of the wound will be evaluated by a specialist physician and recorded by a certificate independent of the research. Higher scores mean a worse outcome for diabetic food ulcer.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start12 Dec 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Aslan, Harran University
- Investigators
- Fatma ASLAN, Principal investigator, Harran Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316115
- Sponsor's protocol ID
- HRRU-KMY-FA-01
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bagcivan G, Ozen N, Bayrak D, Cinar FI. Does Being A Cancer Patient or Family Caregiver of A Cancer Patient Affect Stem Cell Donation Awareness? Asia Pac J Oncol Nurs. 2019 Jul 3;7(1):36-43. doi: 10.4103/apjon.apjon_22_19. eCollection 2020 Jan-Mar.
PubMed 31879682Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.
PubMed 37318078Aslan F, Tosun B, Altinok Ersoy N, Ozen N. The effect of a stress ball on pain and anxiety during sharp debridement in patients with diabetic foot ulcers: A randomized controlled, single-blind study. J Tissue Viability. 2025 May;34(2):100861. doi: 10.1016/j.jtv.2025.100861. Epub 2025 Jan 26.
PubMed 39892227
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
- ClinicalTrials.gov ID
- NCT06316115
- Acronym / sponsor ID
- HRRU-KMY-FA-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- diabetic food ulcer, stress ball, pain, anxciety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 18 Mar 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.
Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement.
Detailed description
The annual number of patients hospitalized with diabetic foot ulcer treatment is 543, and the sample calculation of the study was determined using the G*Power program. Since there was no previous study conducted in the same study group, a study examining the effect of stress ball on pain in invasive procedures was taken as reference in the calculation of the sample. In this study, it was predicted that the difference between pain intensities would be evaluated with a t test, and the effect value was predicted to be 0.70 with a 95% confidence interval and 80% power, and it was calculated that 34 participants would be sufficient for the sample. Considering possible losses from the study (hospitalization, death, changing treatment center, etc.), a total of 76 patients, 38 in each group, were aimed to be included in the study.
As a data collection tool; Introductory Information Form, Meggit-Wagner Classification, Visual Comparison Scale and State Anxiety Scale (STAI) will be used.
Intervention Group: Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure, and each patient will be debrided by the same person throughout the procedure. The patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure.
Control Group: The patient's pain and anxiety will be evaluated by a nurse independent of the research before and during the debridement procedure, without any intervention to the patients.
Stress ball use: Before starting the study, the researchers explained to the patients theoretically how to use the stress ball and demonstrated it practically. Then, the patient was asked to use the ball and it was confirmed whether he was using it correctly. Patients will be asked to count to three, squeeze the ball once and then relax it, inhale each time they squeeze the ball, and exhale when they relax it. The stress ball used is made of medium hardness and high quality silicone. The balls will be provided by the researchers and given to the patients. Patients will use the stress ball throughout the debridement procedure and will continue to use it until the procedure is completed. Statistical significance level will be accepted as p <0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound debridement of patients with diabetic foot ulcers | No intervention | –No Intervention: The patient's pain and anxiety will be evaluated by a nurse independent of the research before and during the debridement procedure, without any intervention to the patients |
| Patients with diabetic foot ulcers using stress balls during wound debridement | Experimental | Other: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp DebrıdementIntervention Group: Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure, and each patient will be debrided by the same person throughout the procedure. The patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being 18 years or older,
- Being an inpatient in the endocrinology clinic,
- Volunteer,
- No communication problems (No hearing, understanding and speaking problems),
- Being a patient diagnosed with diabetic foot ulcer,
Key exclusion criteria (3 listed)
- No pain according to the Visual Comparison Scale,
- Before performing sharp debridement, an intervention decision was taken to reduce pain (local anesthesia).
- administered, nerve blockade, opioid analgesics, etc.) excluded.
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 |
|---|---|---|
| In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp DebrıdementPatients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure, and each patient will be debrided by the same person throughout the procedure. The patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure. | Other | Patients with diabetic foot ulcers using stress balls during wound debridement |
Primary outcome
Introductory Information Form
Time frame: at enrollment
Introductory information formula section by examining studies conducted with products diagnosed with diabetic foot ulcers. Promotional information regime; People's birth year, education level, employment status, income level, place of residence, year of diabetes diagnosis, etc. A total of 13 questions will be asked about.
1 secondary outcome
Meggit-Wagner classification of diabetic foot
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 31879682Bagcivan G, Ozen N, Bayrak D, Cinar FI. Does Being A Cancer Patient or Family Caregiver of A Cancer Patient Affect Stem Cell Donation Awareness? Asia Pac J Oncol Nurs. 2019 Jul 3;7(1):36-43. doi: 10.4103/apjon.apjon_22_19. eCollection 2020 Jan-Mar.
- Results publication: PubMed 37318078Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.
- Derived from this study: PubMed 39892227Aslan F, Tosun B, Altinok Ersoy N, Ozen N. The effect of a stress ball on pain and anxiety during sharp debridement in patients with diabetic foot ulcers: A randomized controlled, single-blind study. J Tissue Viability. 2025 May;34(2):100861. doi: 10.1016/j.jtv.2025.100861. Epub 2025 Jan 26.
- Individual participant dataSharing planned: No
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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.
Fatma ASLAN principal investigator
Harran Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement in people with Diabetic Foot Ulcer, run by Harran University 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma ASLAN (+905427760715, fatmaaslan62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316115, which also lists 3 linked publications.
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 18 Mar 2024.