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

NCT05888818 | Unknown DMC

• 1 other identifier: 2022/16-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  two year

• 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.

  two year

• Antiemetic use status of the groups

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

  two year

Study Arms (2)

cold application group

EXPERIMENTAL

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

Other: Cold application

standard treatment

NO INTERVENTION

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

Interventions

Cold application OTHER

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

cold application group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• Patients who do not volunteer to participate in the study will not be included in the study.

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University

Zonguldak, Kozlu, 67100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Postoperative Nausea and Vomiting; Nausea

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Nigar AK TURKİS, PhD student

  Zonguldak Bulent Ecevit University,PhD student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nigar AK TURKİS, PhD student

CONTACT

+905066926811; niiggaar_78@hotmail.com

Nurten TASDEMİR, associate professor

CONTACT

+905072344018; ntasdemir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate in Surgical Nursing Science

Model Details: There is an experimental and a control group.The distribution of the patients to the groups was made according to the random numbers table obtained by using the index formulas and randomly in the excel program in the web environment.

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 5, 2023
• Study Start: October 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: October 30, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)