NCT07100041

Brief Summary

In burn patients, failure to effectively manage pain and pain-related anxiety negatively affects the healing process; therefore, pain and anxiety must be carefully managed in burn patients. In addition to managing pain and anxiety, providing comfort-based care also contributes to improving the individual's health and recovery. In this study, the effect of breathing exercises and stress ball use during dressing changes on pain, anxiety, and vital signs in burn patients will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable anxiety

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

First Submitted

Initial submission to the registry

July 22, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2025

Completed
Last Updated

December 31, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 22, 2025

Last Update Submit

December 25, 2025

Conditions

AnxietyBreathing ExerciseBurns (Physical Finding)PainPain ManagementStress Ball

Keywords

anxietybreathing exerciseburnspainpain managementstress ball

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS) Results

    The VAS is a 10 cm horizontal line with numbers from 0 to 10, representing no pain at the start and the most severe pain that patients can feel at the end. On the scale, "0" means no pain and "10" means very severe pain. Participants are asked to select a number between "0" and "10" according to the degree of pain they feel.

    immediately before dressing, during dressing, immediately after dressing

Secondary Outcomes (3)

  • Patient Identification and Demographic Information Form

    5 minutes before the first dressing change

  • Burn-Specific Pain Anxiety Scores Assessed Before Dressing

    immediately before dressing

  • Patient Comfort Measured After Wound Dressing

    immediately after dressing

Study Arms (3)

Control (Standard Treatment) Group

EXPERIMENTAL

The standard dressing procedure in the control group is as follows: The protective covering over the wound is removed, and the wound is washed with an irrigation solution. Appropriate medications (decontamination and moisturising gel, debridement gel, alginate, antibiotics, and medications that promote cell regeneration) are applied based on the condition of the wound. A non-adhesive wound care dressing is then placed over the wound, and gauze is applied on top to cover it. Analgesia is not routinely administered in standard wound care. The dressing procedure takes an average of 5 minutes, depending on the size of the burn wound. In the control group, before the dressing procedure, the patient who volunteered to participate in the study will be given a patient information form, a burn-specific pain anxiety scale, and the pain level before dressing will be recorded using the Visual Analogue Scale (VAS) and vital signs will be checked, after which the standard dressing procedure will be

Other: Control (Standard Treatment) Group

Breathing Exercise Group

EXPERIMENTAL

Before the dressing procedure, patients who volunteer to participate in the study will be given a patient information form, a burn-specific pain anxiety scale, and their pain level before dressing will be recorded using the GAS. After their vital signs are checked, they will be given a practical demonstration of breathing exercises. The breathing exercise will first be explained verbally by the project coordinator in the burn centre's training room, followed by a practical demonstration. The patient will then be asked to perform the exercise. Once the project coordinator is confident that the patient has learned how to perform the breathing exercise, the patient will be taken to the dressing room. During the standard dressing procedure, the patient will be instructed to continue performing the breathing exercise. Immediately before the dressing change, the patient will be positioned comfortably, and they will be instructed to use the breathing exerci

Other: Breathing Exercise Group

Stress Ball Group

EXPERIMENTAL

The stress ball is made of a medium-hard plastic material that can be easily held in the hand. Before the dressing procedure, patients who volunteer to participate in the study will be given information about the use of the stress ball after the patient information form, the burn-specific pain and anxiety scale, and the pain level before dressing have been recorded using the GAS, and their vital signs have been checked. During the standard dressing procedure, patients will be instructed to squeeze and release the stress ball periodically until the dressing procedure is complete, focusing solely on the stress ball during this time (Ozen et al., 2023) (Kasar et al., 2020). A separate stress ball will be used for each patient in the stress ball group to ensure that the effectiveness of the stress ball remains consistent. To support patients' relaxation during the dressing procedure, a stress ball usage guide prepared by the project team will be provided via tablet. The

Other: Stress Ball Group

Interventions

Breathing Exercise GroupOTHER

Before the dressing procedure, patients who volunteer to participate in the study will be given a patient information form, a burn-specific pain anxiety scale, and their pain level before dressing will be recorded using the GAS. After their vital signs are checked, they will be given a practical demonstration of breathing exercises. The breathing exercise will first be explained verbally by the project coordinator in the burn centre's training room, followed by a practical demonstration. The patient will then be asked to perform the exercise. Once the project coordinator is confident that the patient has learned how to perform the breathing exercise, the patient will be taken to the dressing room. During the standard dressing procedure, the patient will be instructed to continue performing the breathing exercise. Immediately before the dressing change, the patient will be positioned comfortably, and they will be instructed to use the breathing

Breathing Exercise Group
Stress Ball GroupOTHER

The stress ball is made of a medium-hard plastic material that can be easily held in the hand. Before the dressing procedure, patients who volunteer to participate in the study will be given information about the use of the stress ball after the patient information form, the burn-specific pain and anxiety scale, and the pain level before dressing have been recorded using the GAS, and their vital signs have been checked. During the standard dressing procedure, patients will be instructed to squeeze and release the stress ball periodically until the dressing procedure is complete, focusing solely on the stress ball during this time (Ozen et al., 2023) (Kasar et al., 2020). A separate stress ball will be used for each patient in the stress ball group to ensure that the effectiveness of the stress ball remains consistent. To support patients' relaxation during the dressing procedure, a stress ball usage guide prepared by the project team will be provided

Stress Ball Group
Control (Standard Treatment) GroupOTHER

The standard dressing procedure in the control group is as follows: The protective covering over the wound is removed, and the wound is washed with an irrigation solution. Appropriate medications (decontamination and moisturising gel, debridement gel, alginate, antibiotics, and medications that promote cell regeneration) are applied based on the condition of the wound. A non-adhesive wound care dressing is then placed over the wound, and gauze is applied on top to cover it. Analgesia is not routinely administered in standard wound care. The dressing procedure takes an average of 5 minutes, depending on the size of the burn wound. In the control group, before the dressing procedure, the patient who volunteered to participate in the study will be given a patient information form, a burn-specific pain anxiety scale, and the pain level before dressing will be recorded using the Visual Analogue Scale (VAS) and vital signs will be checked,

Control (Standard Treatment) Group

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18 and 65, seeking outpatient treatment at the burn centre,
  • Without mental, hearing, visual or physical disabilities,
  • Able to speak and understand Turkish,
  • With a burn injury of 15% or less of the total body surface area (TBSA) and requiring dressing changes,
  • At least three days have passed since the burn injury (the wound has passed the inflammatory phase of healing),
  • Not in the maturation phase of wound healing,
  • Burn area is on the hand, arm, leg, foot, or torso,
  • No active burns on the hands,
  • No respiratory issues.

You may not qualify if:

  • Patients with neurological or psychiatric disorders,
  • Patients with burns covering less than 15% of their body surface area or with no second-degree burns,
  • Patients with burns in areas other than the hands, arms, legs, feet, and torso,
  • Patients admitted to the burn centre,
  • Patients with inhalation burns,
  • Patients who receive sedation during dressing changes,
  • Patients with complications such as infection or bleeding in the burn area,
  • Patients who use pharmacological or non-pharmacological methods that may affect pain during dressing changes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Adana City Training and Research Hospital Burn Centre

Adana, Turkey (Türkiye)

Location

Related Publications (10)

  • Sarıtaş, S. Ç., Çevik, S., & Özden, G. (2018). Genel Konfor Ölçeği Kısa Formunun Türkçe Geçerlik ve Güvenirlik Çalışlması. Diyabet, Obezite ve Hipertansiyonda Hemflirelik Forumu Dergisi, 10(2), 16-22.

    BACKGROUND

  • Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010.

    PMID: 17099440BACKGROUND

  • Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.

    PMID: 35397973BACKGROUND

  • Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.

    PMID: 36480101BACKGROUND

  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PMID: 22588748BACKGROUND

  • Fatma Eti Aslan. (2004). Sensitivity and selectivity of visual analog scale and the verbal rating scale in the assessment of postoperative pain. J. Intensive Care Nurs., 8, 1-6.

    BACKGROUND

  • 4. Bozorgnejad, M., Zarei, M. R., Mamashli, L., & Mohaddes Ardebili, F. (2019). The Effect of Rhythmic Breathing on the Anxiety of Dressing Change in Burning Patients. International Electronic Journal of Medicine, 8(2), 95-100. https://doi.org/10.34172/iejm.2019.04

    BACKGROUND

  • Najafi Ghezeljeh T, Mohades Ardebili F, Rafii F. The effects of massage and music on pain, anxiety and relaxation in burn patients: Randomized controlled clinical trial. Burns. 2017 Aug;43(5):1034-1043. doi: 10.1016/j.burns.2017.01.011. Epub 2017 Feb 4.

    PMID: 28169080BACKGROUND

  • 7. Erbay, Ö., Yıldırım, Y., Fadıloğlu, Ç., & Şenuzun Aykar, F. (2019). Use of the Kolcaba's Comfort Theory in the Nursing Management of a Case with a Colostomy Opened Due to Rectum Cancer. Journal of Traditional Medical Complementary Therapies, 2(1), 42-48. https://doi.org/10.5336/jtracom.2019-64998

    BACKGROUND

  • Lee HW, Ang L, Kim JT, Lee MS. Aromatherapy for Symptom Relief in Patients with Burn: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2021 Dec 21;58(1):1. doi: 10.3390/medicina58010001.

    PMID: 35056310BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersBurnsPainAgnosia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Mental DisordersWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study consists of three groups: a control group, a breathing exercise group, and a stress ball group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science in Nursing

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 1, 2025

Study Start

August 4, 2025

Primary Completion

December 2, 2025

Study Completion

December 2, 2025

Last Updated

December 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared in order to protect ethical constraints and participant confidentiality.

Locations

TU(1)