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IRCT20250306064953N2 IRCT 2025-06-02 College of Nursing/University of Baghdad Comfort Without Medications: Nurse-Led Ways to Reduce Pain and Anxiety During Drain Removal After Bariatric Surgery NIPAR-B A nurse-led, Non-Pharmacological Interventions for Pain and Anxiety Reduction During Drain Tube Removal among Bariatric Patients: A Randomized Comparative Trial 2025-03-01 anticipated 40 Complete https://irct.ir/trial/83388 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure the integrity of a randomization procedure that is both transparent and grounded in scientific principles, probability sampling (simple randomization) will be used in assigning patients to cold gel packs, deep breathing exercises, and control groups with the presumption that every patient has an equal probability of being placed in any particular group. During the randomization process, one letter will be selected from a sealed envelope containing three letters. On the back side of every card, the letters ‘A,’ ‘B,’ ‘C,’ ‘D,' or ‘E' will be written (A will be in the cold gel packs group, B will be in the deep breathing exercises group, C will be in the combination group, D in the meditation group, and E will be in the control group), Blinding description: In this single-blind design, the researcher will preserve the gel packs in the freezer for at least 2 hours before covering them with a single layer of medical-grade gauze, and They will be instructed to inhale deeply through their nose and exhale slowly through semi-closed lips while keeping their eyes closed for 5 min. N/A Bariatric Surgery. Intervention 1: Intervention group: Cold Gel Packs. The cold application technique involves the removal of a drain tube with the use of a cooling gel pack. The researcher will preserve the gel packs in the freezer for at least 2 hours before covering them with a single layer of medical-grade gauze. The packs will then be applied to the area surrounding the drain tube for 10–20 minutes before their withdrawal. This technique has been proven effective in reducing discomfort and pain during the removal process. Intervention 2: Intervention group: Deep Breathing Exercises. Another technique is the deep breathing exercise technique. They will be instructed to inhale deeply through their nose and exhale slowly through semi-closed lips while keeping their eyes closed for 5 min. Participants will be asked to perform breathing exercises before removing the drain tube. This technique has been shown to reduce anxiety and promote relaxation during the procedure. Intervention 3: Intervention group: Combination of cold gel packs and deep breathing exercises. The researcher will preserve the gel packs in the freezer for at least 2 hours before covering them with a single layer of medical-grade gauze. The packs will then be applied to the area surrounding the drain tube for 10–20 minutes before their withdrawal. They will be instructed to inhale deeply through their nose and exhale slowly through semi-closed lips while keeping their eyes closed for 5 min. Participants will be asked to perform breathing exercises before removing the drain tube. Intervention 4: Intervention group: Guided meditation. Guided imagery therapy can incorporate the use of relaxation techniques, such as diaphragmatic breathing and a musical background, to help the participant focus and stay focused. The therapy session started with soft background music with nature sounds (sea and seagulls) and audio that invited the participant to stand in a comfortable position on the bed with their eyes closed and then perform movements of slow and expansive breathing and relaxation in various parts of the body. Intervention 5: Control group: The drain tube removal will be performed without any intervention. Participants in the control group will receive routine standard care during drain tube removal, without any additional non-pharmacological interventions. This includes general reassurance and standard nursing practices typically performed during the procedure, such as verbal communication and basic comfort measures, but excludes specific interventions like cold gel packs, guided breathing, or meditation. Yes - There is a plan to make this available What will be shared: The data will be the results of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory that measures patients' anxiety levels and a numerical pain scale to measure pain levels in both control and intervention groups. When: God willing, once the process of data collection, analysis, and successfully publishing the manuscript is finished, all the related files will become available for 6 months after publication. To whom: With academic nurses and any researcher who is interested in the data. Conditions: The data could be used after getting the permission via email. Also, users need to acknowledge the owner Where to obtain: Users can ask for the data and the permission via email. Ali Malik Tiryag is the corresponding author. He will be in contact with whoever asks for the data. His email is ali.malik@uobasrah.edu.iq How to obtain: Users can ask for the data and the permission via email. Ali Malik Tiryag is the corresponding author. He will be in contact with whoever asks for the data. His email is ali.malik@uobasrah.edu.iq Comments: Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfill their academic endeavors.
public Ali Malik Tiryag
Basrah Center, Bab Al-Zubair Campus
Basrah Iraq 61004 +964 781 173 5332 ali.malik@uobasrah.edu.iq College of Nursing/University of Baghdad scientific Ali Malik Tiryag
Basrah Center, Bab Al-Zubair Campus
Basrah Iraq 61004 +964 781 173 5332 ali.malik@uobasrah.edu.iq College of Nursing/University of Baghdad Iraq Adults aged 18–60 years Underwent bariatric surgery (e.g., sleeve gastrectomy, gastric bypass) with postoperative surgical drain placement. Conscious, oriented, and able to communicate effectively in the language used for interventions and assessments. Drain tube scheduled for removal within 48–72 hours postoperatively. Willing to participate and provide written informed consent. Stable vital signs (as determined by the attending physician/nurse). Pain score ≥3 on a 0–10 numerical rating scale before the drain removal (to ensure intervention relevance). 18 years 65 years Both Psychiatric or cognitive disorders that interfere with communication, comprehension, or cooperation (e.g., dementia, schizophrenia). Hearing or visual impairments that would hinder the ability to participate in guided meditation or deep breathing instructions. Use of sedatives, opioids, or anxiolytics within 4 hours prior to the drain removal. Postoperative complications (e.g., infection, bleeding, hemodynamic instability) that might require emergency care. Known allergy or intolerance to cold therapy or materials used in gel packs. History of chronic pain conditions or current use of long-term pain management therapy. Participation in another clinical trial that may interfere with this study. L98.7 Excessive and redundant skin and subcutaneous tissue Other Other Other Other N/A Intervention group: Cold Gel Packs. The cold application technique involves the removal of a drain tube with the use of a cooling gel pack. The researcher will preserve the gel packs in the freezer for at least 2 hours before covering them with a single layer of medical-grade gauze. The packs will then be applied to the area surrounding the drain tube for 10–20 minutes before their withdrawal. This technique has been proven effective in reducing discomfort and pain during the removal process. Intervention group: Deep Breathing Exercises. Another technique is the deep breathing exercise technique. They will be instructed to inhale deeply through their nose and exhale slowly through semi-closed lips while keeping their eyes closed for 5 min. Participants will be asked to perform breathing exercises before removing the drain tube. This technique has been shown to reduce anxiety and promote relaxation during the procedure. Intervention group: Combination of cold gel packs and deep breathing exercises. The researcher will preserve the gel packs in the freezer for at least 2 hours before covering them with a single layer of medical-grade gauze. The packs will then be applied to the area surrounding the drain tube for 10–20 minutes before their withdrawal. They will be instructed to inhale deeply through their nose and exhale slowly through semi-closed lips while keeping their eyes closed for 5 min. Participants will be asked to perform breathing exercises before removing the drain tube. Intervention group: Guided meditation. Guided imagery therapy can incorporate the use of relaxation techniques, such as diaphragmatic breathing and a musical background, to help the participant focus and stay focused. The therapy session started with soft background music with nature sounds (sea and seagulls) and audio that invited the participant to stand in a comfortable position on the bed with their eyes closed and then perform movements of slow and expansive breathing and relaxation in various parts of the body. Control group: The drain tube removal will be performed without any intervention. Participants in the control group will receive routine standard care during drain tube removal, without any additional non-pharmacological interventions. This includes general reassurance and standard nursing practices typically performed during the procedure, such as verbal communication and basic comfort measures, but excludes specific interventions like cold gel packs, guided breathing, or meditation. Reduction in self-reported pain and anxiety levels during drain tube removal through nurse-led, non-pharmacological interventions in bariatric patients. Timepoint: Twenty minutes Before intervention and immediately after intervention. Method of measurement: Patients will be asked to rate their pain by using the Visual Analogue Scale (0-10) before and immediately after drain tube removal. A lower number (0) indicates no pain; (1-3) indicates mild pain, (4-6) moderate pain, (7-9) severe pain, and (10) indicates the worst pain. Also, anxiety levels will be measured by using a six-item state anxiety scale derived from the State-Trait Anxiety Inventory, which consists of six items only, each item [1: No at all, 2: Somewhat, 3: Moderate So, 4: Very much so] before and immediately after drain tube removal. 1. Physiological responses during drain removal. Timepoint: Changes in heart rate, blood pressure, and respiratory rate will be measured before and after the procedure to objectively assess stress and anxiety levels. Method of measurement: sphygmomanometer for blood pressure measurement and pulse oximetry for oxygen saturation. 2. Patient satisfaction with care. Timepoint: before and after intervention. Method of measurement: Assessed using a validated satisfaction scale or Likert-type questionnaire to evaluate patients' perceptions of the nurse-led interventions. 3. Procedure duration. Timepoint: before and after intervention. Method of measurement: Time taken to complete the drain removal, recorded in minutes, to determine whether the interventions affect procedural efficiency. The author of the trial is the funding source Approved 2025-05-06 Ethics committee of Baghdad college of nursing Bab Al Muadham Baghdad Baghdad Iraq