CClinicalTrials.gg
CompletedNCT05888818Updated Sep 9, 2026

The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period

An interventional study of Cold application in Local Application/Packing Too Cold, Patient Satisfaction and Postoperative Nausea and Vomiting, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Zonguldak Bulent Ecevit University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2022, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

As a result of the literature review, it has been seen that it has not yet been clarified whether cold application methods are effective on postoperative nausea and vomiting, and academic studies on this subject are needed.

The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period.

The research hypotheses are as follows:

H1:Cold application method reduces nausea and vomiting in the early postoperative period.

H1:The cold application method reduces the need for antiemetic drugs in the early postoperative period.

H1:Cold application method in the early postoperative period increases patient satisfaction.

Condition or disease:

Postoperative nausea and vomiting,Postoperative antiemetic use status,Patient satisfaction,Effects of cold application method

Intervention/treatment:

There is an intervention group in which the cold application method is applied.

Read the detailed description

The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period.

The population of the study will consist of patients who are planned to undergo laparoscopic cholecystectomy under general anesthesia in the Department of General Surgery, Zonguldak Bülent Ecevit University Health Practice and Research Center between October 2022 and October 2024.Çalışmanın örneklemini laparoskopik kolesistektomi planlanan, dahil edilme kriterlerini karşılayan ve çalışmaya katılmaya gönüllü olan hastalar oluşturacaktır.

As a result of the GPower power analysis, it was calculated that at least 60 people (at least 30 people for each group) who met the inclusion criteria of the research should be taken in order to obtain 80% power at the 95% confidence interval for the d=0.8 effect size.

Data collecting:

The collection of research data will be carried out in three stages.

  1. stage:Patients scheduled for laparoscopic cholecystectomy who have undergone hospitalization will be evaluated in terms of their eligibility for inclusion criteria, and eligible patients will be invited to participate in the study.The purpose of the research will be explained to the patients, the informed consent form will be read, written and verbal consent will be obtained and a copy of the form will be given to the patients.Then, the patient information data collection form and Apfel risk score will be filled with face-to-face interview technique, and the answers given by the patients will be recorded.
  2. stage: The surgery will be held in the recovery room.While the patients in the intervention group are in the recovery room after the surgery, their routine applications will be made and the state of consciousness and alertness will be checked.After the application, the presence of nausea, severity, vomiting status, vital signs (blood pressure, pulse, respiratory rate, body temperature) will be measured.Then, a cold application (with a cold gel pack) will be applied to the nape area for 5 minutes.Presence of nausea, severity, vomiting status, vital signs will be re-measured immediately after the application.Antiemetic drug use and opioid drug use will be questioned.
  3. stage:Presence, severity and presence of nausea will be re-evaluated at the 2nd and 6th hours of the experimental and control group patients.Antiemetic drug use and opioid drug use will be questioned.Patient satisfaction will be evaluated.
02

Conditions studied

  • Local Application/Packing Too Cold
  • Patient Satisfaction
  • Postoperative Nausea and Vomiting

Keywords

  • Nausea and vomiting after surgery,cold application methods,nursing care after surgery,alternative and complementary methods,postoperative care,cholecystectomy
  • Patient satisfaction
03

In context

Patient Satisfaction

256 studies on the registry are indexed under Patient Satisfaction; 127 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 196 interventional studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Those who will undergo elective surgery
  • Attempting laparoscopic cholecystectomy
  • Those between the ages of 18-65
  • Those who will receive general anesthesia
  • Not allergic to cold
  • Body temperature ≥36°C
  • ASA I and ASA II class
  • Those with an Apfel risk score of 2 and above
  • Postoperative nausea severity of 2 and above
  • Without chronic disease
  • Neurological problems
  • No problem communicating,• No hearing and vision problems
  • Being conscious, awake and oriented after surgery,
  • Patients who volunteer to participate in the study will be included in the study

Exclusion criteria

Exclusion Criteria:

  • Those who are allergic to cold
  • Body temperature \<36°C,
  • Those who have a disability, incision and surgical procedure around the head and neck
  • Having chronic illness
  • Having neurological problems
  • Having nasogastric tube
  • Postoperatively conscious, awake and not oriented,
  • Not eligible for inclusion criteria and
  • Patients who do not volunteer to participate in the study will not be included in the study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    cold application group

    A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.

    Other: Cold application

  • No intervention
    standard treatment

    No application will be made and the presence of nausea, severity, vomiting and vital signs will be measured after 5 minutes.

Interventions

  • OtherCold application

    A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.

06

What researchers measure

Primary outcomes

  1. Determining the mean scores of the experimental and control groups from the nausea numerical scale

    Nausea Numerical Scale There are numbers from 0 to 10 on the scale.The scale is explained to the patients and asked to choose the number between 0 and 10 that best reflects their nausea. Zero usually indicates 'no nausea' while 10 represents 'unbearable nausea'. Evaluation will be made in the recovery room after the surgery, then at the 2nd and 6th hours.

    Time frame: two year

  2. Determination of patient satisfaction of the experimental and control groups

    The patient satisfaction scale is used to evaluate patient satisfaction.It consists of numbers between "0" and "10" to determine the satisfaction level of the patients after the A value of zero indicates "no satisfaction" with the practice, while a value of ten indicates "a lot of satisfaction". Satisfaction scale will be evaluated at the 6th hour after the surgery.

    Time frame: two year

  3. Antiemetic use status of the groups

    The patients' use of antiemetics after surgery will be questioned.

    Time frame: two year

07

Study locations

1 site
  • Zonguldak Bulent Ecevit University
    Zonguldak, Kozlu 67100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05888818
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
Nigar Ak Turkis (Doctoral Candidate in Surgical Nursing Science, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Jun 5, 2023
Start date
Oct 1, 2022
Primary completion
Jul 30, 2023
Completion
Oct 30, 2024
Last update
Sep 9, 2026

Study contacts

Nigar AK TURKİS, PhD student
principal investigator · Zonguldak Bulent Ecevit University,PhD student

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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