The Effect of Cold Application on Nausea and Vomiting After Bariatric Surgery

NCT07825779 | Completed

• 1 other identifier: E-43012747-050.04-463784-238
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a chronic disease resulting from an excess of body fat mass relative to lean body mass, characterized by a deterioration in the individual's quality of life and health (Kayar and Utku, 2013; Usta and Çavdar, 2013; Tam and Çakır, 2012; Tuncalı et al., 2018). Bariatric surgery is becoming increasingly common worldwide. Nausea and vomiting are among the most frequently observed complications in these patients. This study will be conducted to assess patients for the risk of nausea and vomiting and to examine the effects of a cold application nursing intervention. The lack of sufficient literature measuring nausea and vomiting in patients following bariatric surgery prompted us to undertake this study.

Conditions

Obese Patients With Bariatric Surgery

Keywords

obese patients; nausea and vomiting; cold application

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  The VAS is a scale ranging from 0 ("no nausea") to 10 ("very severe nausea"), with numerical values assigned at one-centimeter intervals. The following were rated: nausea severity, peak nausea severity, nausea severity during activity, nausea severity at rest, retching/vomiting severity, and peak retching/vomiting severity.

  15 months

Secondary Outcomes (1)

• Apfel Nausea and Vomiting Risk Score

  15 MONTHS

Other Outcomes (1)

• The EQ-5D-5L form consists of two parts: the descriptive system and the Visual Analogue Scale (VAS).

  15 months

Study Arms (2)

Experimental group subjected to ice application

EXPERIMENTAL

Upon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded.

Other: ICE

CONTROL

NO INTERVENTION

When the individual arrived at the unit, their nausea status (including severity) and vomiting status were assessed, and physiological parameters were measured prior to the intervention. No cold application was performed. Following the procedure, nausea status (including severity), vomiting status, and physiological parameters were reassessed. The use of antiemetic and opioid medications was also recorded.

Interventions

ICE OTHER

Upon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded.

Also known as: Experimental group subjected to ice application

Experimental group subjected to ice application

Eligibility Criteria

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

You may qualify if:

• Individuals over the age of 18
• Patients accessible prior to surgery
• Those scheduled to receive general anesthesia only
• Conscious individuals
• Individuals without cognitive or psychiatric disorders

You may not qualify if:

• Individuals under the age of 18
• Those who experienced serious complications during or after surgery
• Individuals with hearing, visual, speech, or cognitive dysfunction
• Those without neurological problems
• Patients who do not consent to the procedure

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, SERDİVAN, 54050, Turkey (Türkiye)

Location

Related Publications (2)

• Scharfenberg DR, Salcido A, Malone P, Clark J, Steele MA. Managing Postoperative Nausea With an Application of Ice Pack to the Posterior Upper Neck. J Perianesth Nurs. 2022 Dec;37(6):774-777. doi: 10.1016/j.jopan.2021.12.010. Epub 2022 May 28.

  PMID: 35637077 BACKGROUND

• Gecit S, Ozbayir T. Evaluation of Preoperative Risk Assessment and Postoperative Nausea and Vomiting: Importance for Nurses. J Perianesth Nurs. 2020 Dec;35(6):625-629. doi: 10.1016/j.jopan.2020.04.006. Epub 2020 Aug 7.

  PMID: 32778493 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ice

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Özlem Doğu, PhD

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFFESSOR

Model Details: Patients are transferred to the gastrointestinal surgery ward following their surgery. Postoperative Metpamid (10 mg/2 mL) is routinely administered to prevent postoperative nausea and vomiting (PONV). Upon arrival at the ward, patients' vital signs are checked by a nurse and recorded in the observation chart. Treatments prescribed by the physician are administered and documented. If patients are sufficiently motivated and their pain is controlled, they are mobilized after the 4th or 6th hour and continue walking every two hours during the first day following mobilization.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 17, 2026
• Study Start: May 1, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)