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NCT Number: NCT07825779

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

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.

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Key information

Conditions

Obese Patients With Bariatric Surgery Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University

Sakarya, SERDİVAN, 54050, Turkey (Türkiye)

About this study

The analysis of the patients' pre- and post-operative scale scores in this study is expected to reveal an improvement in quality of life, consistent with the findings of similar studies. It is anticipated that the patients' quality of life will increase as they achieve their desired weight and body image, gain mobility, and become more independent in their daily lives. Quality of life is defined as the level of satisfaction shaped by an individual's abilities and lifestyle. Obesity frequently impacts quality of life negatively by affecting the individual psychosocially-particularly through dissatisfaction with their physical appearance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Experimental group subjected to ice application

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 15 months

    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.

Secondary outcomes

  1. Apfel Nausea and Vomiting Risk Score

    Time frame: 15 MONTHS

    To predict the development of postoperative nausea and vomiting, the Apfel Risk Score assesses four factors: female gender, non-smoking status, a history of postoperative nausea and vomiting or motion sickness, and postoperative opioid use. Each factor is assigned 1 point. The Apfel risk score ranges from 0 to 4 and is classified into low, moderate, and high-risk categories. An Apfel risk score of 0-1 indicates low risk, 2 indicates moderate risk, and 3-4 indicates high risk.

Other outcomes

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

    Time frame: 15 months

    Descriptive System (5 Dimensions and 5 Levels)

    This assesses the individual's health status on the day of evaluation across 5 different dimensions. There are 5 response levels for each dimension:

    Mobility: The ability to walk and perform physical movements. Self-care: Personal care skills such as washing and dressing. Usual Activities: Work, education, housework, family, or leisure activities. Pain/Discomfort: Pain and physical discomfort felt in the body. Anxiety/Depression: Mental and emotional state. There are 5 response options for each section: "no problems," "slight problems," "moderate problems," "severe problems," and "extreme problems."

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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