The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy

NCT05149612 | Unknown

• 1 other identifier: cholecystectomy
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters (blood pressure, pulse, respiratory rate, pain score, oxygen saturation. The hypothesis of the study: To see the effect of hot application and its effect on physiological parameters after hot application in individuals who have undergone laparoscopic cholecystectomy. The population of the study will consist of patients who were admitted to the OMU SUVAM General Surgery Service and underwent laparoscopic cholecystectomy. The sample of the study will consist of individuals who have undergone 84 laparoscopic cholecystectomy operations, who agreed to participate in the study, and who met the criteria for inclusion in the study, between the specified dates. The sample size of the study was determined in the G\*Power 3.1.9.4 program by considering Cohen's standard effect sizes. Effect size was calculated based on 0.25, Type I error 0.05, Type II error 0.20 (80% power) and 38 patients were calculated for each group, but considering data loss, it was aimed to reach 10% more, with 42 patients for each group and 84 patients in total. Which group the individuals in the sample group would be in was determined by randomization, and a randomization table was created over two groups. In the study, data will be collected using the Patient Information Form, Visual Analogue Scale (VAS) and Physiological Parameter Form. The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged. When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.

Conditions

Cholecystectomy; Nursing Caries; Shoulder Pain

Keywords

hot application; postoperative pain; nursing care; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (6)

• Pain Score

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  At the 0th minute right after the patients come from the operation

• Pain Score

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  At the 30th minute after the patients come from the operation

• Pain Score

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  At the 4th hour after the patients come from the operation,

• Pain Score

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  At the 12th hour after the patients come from the operation

• Pain Score

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  At the 24th hour after the patients come from the operation

• pain Score

  The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

  At the 48th hour after the patients come from the operation

Study Arms (2)

Heat Therapy Group

EXPERIMENTAL

The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged.

Other: Heat Therapy

Control group

NO INTERVENTION

When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.

Interventions

Heat Therapy OTHER

Patients in the intervention group will be treated with hot water bags twice, 20 minutes in the morning and 20 minutes in the evening, starting four hours after the operation until discharge. In accordance with the literature, the water bag filled with 55 ± 2°C hot water will be wrapped with 2 towels. The water bag will be applied to the shoulder area while the patient is in the fawler or semi-fawler position. After 20 minutes, the hot application will be terminated. Pain and physiological parameters of the patients will be evaluated at the 0th minute, 30th minute, 4th hour, 12th hour, 24th hour and 48th hour postoperatively. At the same time, when individuals have pain, analgesics will be administered at the request of the physician.

Heat Therapy Group

Eligibility Criteria

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

You may qualify if:

• who agreed to participate in the research
• years old and over
• BMI within normal limits
• VAS score of 5 or higher

You may not qualify if:

• who refused to participate in the research
• with a history of upper laparotomy
• Having endocrine, renal, hepatic or immunological disease
• ASA (American Society of Anesthesiologists) score above 3
• with chronic shoulder pain
• Regular use of analgesics
• using sedative drugs

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu Üniversitesi

Ordu, Altınordu, 52200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Pain, Postoperative

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Hanife Durgun, PhD

  Ordu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Bayraktar, bachelor's

CONTACT

5530941996; fyzbyrktr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will not be told which group they are in. In order to avoid bias in the data collection phase, support will be received from the nurses working in the general surgery service independently of the research, and from the independent statistical expert, apart from the researcher, in the database of the research.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Assistant Professor

Model Details: The individuals in the sample group will be divided into two groups as the hot application group and the control group. Individuals in the control group will not be treated with heat.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 8, 2021
• Study Start: July 6, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

TU (1)