The 4-7-8 Breathing Technique on Pain and Nausea-Vomiting

NCT06439121 | Completed

• 1 other identifier: PAINVOMIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is planned as a randomized controlled trial to determine the effect of the 4-7-8 breathing technique applied to patients after bariatric surgery on pain and nausea and vomiting. The research will be conducted on 60 patients who underwent bariatric surgery between 05.2024-12.2024. Randomization will be ensured for students who meet the inclusion criteria, and they will be divided into two random groups: the experimental group (n=30) and the control group (n=30). After obtaining consent with the "Informed Consent Form," patients who agree to participate in the study will have the "Patient Introduction Form" filled out by researchers, and they will be provided with training on the 4-7-8 breathing technique. Patients will be instructed to practice the 4-7-8 breathing technique once per hour (4 breaths) post-surgery. Pain and nausea-vomiting will be monitored at 0, 2, 6, 12, and 24 hours during their 24-hour hospital stay. The control group, after consenting with the "Informed Consent Form" the day before surgery, will have the "Patient Introduction Form" filled out by researchers, and their pain and nausea-vomiting status will be monitored at the same intervals during their hospital stay. No interventions will be made for the control group; they will receive routine nursing care during their hospital stay.

Conditions

Pain; Vomiting; Nausea; Post Operative Pain; Vomiting, Postoperative; Nausea, Postoperative

Outcome Measures

Primary Outcomes (3)

• Pain Scale

  During the 24-hour hospital stay, the patient's pain level will be assessed at 0, 2, 6, 12, and 24 hours, and the pain intensity, ranging from 0 for no pain to 10 for severe pain, as indicated by the patient, will be recorded.

  just before operation, just after operation

• Vomitting

  During the 24-hour hospital stay, the patient's nausea level will be observed at 0, 2, 6, 12, and 24 hours, and the occurrence of vomiting, noted as either present or absent, will be recorded.

  just before operation, just after operation

• Nausea

  During the 24-hour hospital stay, the patient's nausea level will be assessed at 0, 2, 6, 12, and 24 hours, and the severity of nausea, ranging from 0 for no nausea to 10 for severe nausea as indicated by the patient, will be recorded.

  just before operation, just after operation

Study Arms (2)

4-7-8 Breathing Technique

EXPERIMENTAL

The Patient Introduction Form comprises three sections. The first section covers sociodemographic characteristics, including gender, age, BMI, education level, smoking status, and family history of obesity (6 questions). The second section addresses medical characteristics such as chronic diseases, ASA score, duration of general anesthesia, type of surgery, surgical complications history, and length of hospital stay (7 questions). The third section evaluates pain and nausea-vomiting using the Visual Analog Scale, a 10 cm horizontal line where patients mark their severity level. Scores range from 0-10, with higher scores indicating increased symptom severity. The scale is versatile, assessing symptoms like pain, anxiety, fatigue, and nausea-vomiting, with vomiting assessed as "present" or "absent." Patients will be taught the 4-7-8 breathing technique pre-surgery and asked to practice it post-surgery. Their responses to the third section's questions will be recorded.

Procedure: 4-7-8 Breathing Technique

Control

NO INTERVENTION

The Patient Introduction Form comprises three sections: 1. Sociodemographic characteristics, encompassing gender, age, BMI, education level, smoking status, and family history of obesity (6 questions). 2. Medical characteristics, including the presence of chronic diseases, ASA score, duration of general anesthesia, type of surgery performed, history of surgical complications, and length of hospital stay (7 questions). 3. Evaluation of pain and nausea-vomiting using the Visual Analog Scale, which entails a 10 cm horizontal line where patients mark their severity level. Scores range from 0-10, with higher scores indicating increased symptom severity. Vomiting will be assessed as "present" or "absent." Patients in the control group will undergo routine monitoring and treatments without interventions, and their responses to the questions from the third section will be recorded.

Interventions

4-7-8 Breathing Technique PROCEDURE

Patients will be instructed to practice the 4-7-8 breathing technique once per hour (4 breaths) post-surgery. Pain and nausea-vomiting will be monitored at 0, 2, 6, 12, and 24 hours during their 24-hour hospital stay.

4-7-8 Breathing Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being aged 18 and above, and under 65 years old
• Patients undergoing laparoscopic general surgery under general anesthesia (such as laparoscopic sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass) will be included in the study.
• Having an ASA Score of I or II
• Being willing to participate in the study

You may not qualify if:

• Not undergoing laparoscopic surgical intervention,
• Having neurological or psychological issues,
• Transferred to the intensive care unit after surgery,
• Emergency and unplanned cases,
• Patients diagnosed with cancer will be excluded from the scope of the study.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara YBU

Yenimahalle, Ankara, 6010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Vomiting; Nausea; Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ankara Yildirim Beyazıt University

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 3, 2024
• Study Start: April 8, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)