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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Pain assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Stress ball (Behavioral)
Control Group
Routine care
结局指标
主要结局
Pain assessment
时间窗: 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.
Anxiety Assesment (The Distress Thermometer)
时间窗: 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.
Physiological Parameters (heart rate, systolic and diastolic blood pressure, oxygen saturation and respiratory rate)
时间窗: 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.
Physiological Parameter: heart rate
时间窗: 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.
Physiological Parameters: systolic and diastolic blood pressure
时间窗: 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
Physiological Parameter: oxygen saturation
时间窗: 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.
Physiological Parameter: respiratory rate
时间窗: 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.
Pain assessment
时间窗: 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.
Anxiety Assesment (The Distress Thermometer)
时间窗: 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.
Physiological Parameters (heart rate, systolic and diastolic blood pressure, oxygen saturation and respiratory rate)
时间窗: 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.
Physiological Parameter: heart rate
时间窗: 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.
Physiological Parameters: systolic and diastolic blood pressure
时间窗: 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
Physiological Parameter: oxygen saturation
时间窗: 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.
Physiological Parameter: respiratory rate
时间窗: 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.
次要结局
未报告次要终点
研究者
Derya Gezer
Assistant Professor
Tarsus University