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A nurse-led, Non-Pharmacological Interventions for Pain and Anxiety Reduction During Drain Tube Removal among Bariatric Patients: A Randomized Comparative Trial

Protocol summary

Study aim
To identify the effect of cold gel packs, deep breathing exercises, a combination of cold gel packs and deep breathing exercises, and guided meditation on pain and anxiety during drain tube removal among post-bariatric surgery patients.
Design
The true experimental (comparative) design. Five study groups (A, B, C, D, and E) will be used in this study for two phases (before and after drain tube removal). For each, 40 patients will be collected by a simple randomization method at a single center.
Settings and conduct
The study will be performed at Al-Basrah Teaching Hospitals (Al-Sader, Al-Faiha, Al-Mawana, Al-Sayyab, and Al-Mawaddah Private Hospital). In a single-blinded design, the researcher will cover the cold gel packs with a single layer of medical-grade gauze, and also, they will be instructed to inhale deeply through their nose and exhale slowly through semi-closed lips.
Participants/Inclusion and exclusion criteria
Inclusion: ages between 18 and 65 years, any bariatric surgery, patients with a BMI > 40 kg/m² or a BMI > 35 kg/m² with comorbid diseases. Exclusion: patients with cancer, communication difficulties, heart failure, liver failure, kidney failure, drug addiction or alcoholism, psychological issues, and sleep disorders.
Intervention groups
The patients were divided into five groups: Group A, cold gel packs. Group B, deep breathing exercises. Group C, a combination of cold gel packs and deep breathing exercises. Group D, guided meditation. Group E, without any intervention.
Main outcome variables
main outcome will be change in the pain and anxiety levels during drain tube removal

General information

Reason for update
Acronym
NIPAR-B
IRCT registration information
IRCT registration number: IRCT20250306064953N2
Registration date: 2025-06-02, 1404/03/12
Registration timing: registered_while_recruiting

Last update: 2025-06-02, 1404/03/12
Update count: 0
Registration date
2025-06-02, 1404/03/12
Registrant information
Name
Ali Tiryag
Name of organization / entity
University of Basrah
Country
Iraq
Phone
+964 781 173 5332
Email address
ali.malik@uobasrah.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-01, 1403/12/11
Expected recruitment end date
2025-07-01, 1404/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A nurse-led, Non-Pharmacological Interventions for Pain and Anxiety Reduction During Drain Tube Removal among Bariatric Patients: A Randomized Comparative Trial
Public title
Comfort Without Medications: Nurse-Led Ways to Reduce Pain and Anxiety During Drain Removal After Bariatric Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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).
Exclusion criteria:
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baghdad college of nursing
Street address
Bab Al Muadham
City
Baghdad
Postal code
10047
Approval date
2025-05-06, 1404/02/16
Ethics committee reference number
50

Health conditions studied

1

Description of health condition studied
Bariatric Surgery
ICD-10 code
L98.7
ICD-10 code description
Excessive and redundant skin and subcutaneous tissue

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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

Description
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

Description
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.

Intervention groups

1

Description
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.
Category
Other

2

Description
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.
Category
Other

3

Description
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.
Category
Other

4

Description
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.
Category
Other

5

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Basrah Teaching Hospital
Full name of responsible person
Ali Malik Tiryag
Street address
Basrah Center, Al-Saadi Street
City
Basrah
Postal code
61004
Phone
+964 781 173 5332
Email
ali.malik@uobasrah.edu.iq
Web page address
https://basrah-health.gov.iq

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Ali Malik Tiryag
Street address
Bab Al Muadham
City
Baghdad
Postal code
10047
Phone
+964 781 173 5332
Email
ali.malik@uobasrah.edu.iq
Web page address
http://conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Ali Malik Tiryag
Position
PhD Student/Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Basrah Center, Bab Al-Zubair Campus
City
Basrah
Province
Basrah
Postal code
61004
Phone
+964 781 173 5332
Email
ali.malik@uobasrah.edu.iq
Web page address
https://faculty.uobasrah.edu.iq/faculty/3300

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Ali Malik Tiryag
Position
PhD Student/Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Basrah Center, Bab Al-Zubair Campus
City
Basrah
Province
Basrah
Postal code
61004
Phone
+964 781 173 5332
Email
ali.malik@uobasrah.edu.iq
Web page address
https://faculty.uobasrah.edu.iq/faculty/3300

Person responsible for updating data

Contact
Name of organization / entity
College of Nursing/University of Baghdad
Full name of responsible person
Ali Malik Tiryag
Position
PhD Student/Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Basrah Center, Bab Al-Zubair Campus
City
Basrah
Province
Basrah
Postal code
61004
Phone
+964 781 173 5332
Email
ali.malik@uobasrah.edu.iq
Web page address
https://faculty.uobasrah.edu.iq/faculty/3300

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
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 data/document is available
With academic nurses and any researcher who is interested in the data.
Under which criteria data/document could be used
The data could be used after getting the permission via email. Also, users need to acknowledge the owner
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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.
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