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The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use

Primary Purpose

Pain, Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
hot application
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Shoulder focused on measuring postlaparoscopic, shoulder pain, analgesic, Hot application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Agreeing to participate in the research,
  2. Having undergone laparoscopic abdominal surgery
  3. Those who have no previous history of surgery

Exclusion Criteria:

  1. Those who did not agree to participate in the research
  2. Those who have had previous abdominal surgery

Sites / Locations

  • Tarsus UniverstyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hot application

control group

Arm Description

After the patients come to the service after the surgery, a thermophore filled with hot water will be placed on the patient's shoulder according to the presence of shoulder pain and it will be ensured that he stays for 15 minutes. Pain assessment will be done before and after the application. However, 0-2-4-8-12-24. Routine pain assessment will be done at In addition, the type, route, effect and amount of analgesic done in this process will also be recorded. Response evaluation will follow. Response evaluation will follow. Hot application will be applied to every shoulder pain reported by the patients.

First, an individual information form will be filled in for the control group patients who meet the sampling criteria. 0-2-4-8-12-24 after the patients come to the service after the surgery. Routine pain assessment will be done at In addition, the type, route, effect and amount of analgesic done in this process will also be recorded. Response evaluation will follow.

Outcomes

Primary Outcome Measures

change of pain
Numerical Pain Rating Scale (NRS) The form used by Williamson & Hoggart (2005) to assess pain, patients will be asked to select a number from 0 to 10 that best describes their current pain. 0 means no pain and 10 means severe pain. It will be scored as no pain (0), mild pain (1-3), moderate (4-7) and severe pain (8-10).
analgesic consumption
analgesic consumption form

Secondary Outcome Measures

Full Information

First Posted
April 9, 2022
Last Updated
August 28, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05334797
Brief Title
The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use
Official Title
The Effect of Hot Application on Shoulder Pain and Analgesic Use After Laparoscopic Upper Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study; To evaluate the effect of hot application on postlaparoscopic shoulder pain and analgesic use in patients undergoing upper laparoscopic surgery in general surgery.
Detailed Description
Among the advantages of laparoscopic surgery; smaller incisions, less postoperative pain, less need for analgesia, shorter hospital stay, earlier return to normal activities and lower morbidity. However, laparoscopic surgery is associated with postoperative shoulder pain, which is rarely seen in open surgeries. The precise mechanism of postlaparoscopic shoulder pain (PLOA) is unclear, but it is believed that the carbon dioxide remaining after laparoscopic surgery causes shoulder pain by causing irritation of the phrenic nerve. In some cases, PLOA may cause more discomfort to the patient than incisional pain. Hot application is an effective method used to relieve pain. Hot application activates the gate control mechanism, stimulating tactile receptors, reducing ischemic pain with vasodilation, removing metabolic wastes, increasing the release of endorphins, eliminating muscle spasm, reducing effects such as pressure, stretching and hypoxia on nerve endings as a result of changes in the viscoelastic properties of tissues, raising the pain threshold, It reduces or relieves pain by sedating and creating relief in the patient. Hot application is easy to use, inexpensive, requires no prior application, and has minimal adverse side effects when used correctly. Heat sources include a hot water heater, an electric heating pad, a warm blanket, and a warm bath or shower. In addition to being used as a pain reliever, heat is used to relieve chills or shivering, reduce joint stiffness, reduce muscle spasm, and increase connective tissue extensibility. In the study of Mohamed et al., in which they examined the effect of hot application and early mobilization on shoulder pain, in the experimental group patients who received hot application; Postoperative shoulder pain was found to be significantly less than the control group at different evaluation times at 4 hours after surgery and at 6, 12 and 24 hours (p<0.001).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Shoulder
Keywords
postlaparoscopic, shoulder pain, analgesic, Hot application

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hot application
Arm Type
Experimental
Arm Description
After the patients come to the service after the surgery, a thermophore filled with hot water will be placed on the patient's shoulder according to the presence of shoulder pain and it will be ensured that he stays for 15 minutes. Pain assessment will be done before and after the application. However, 0-2-4-8-12-24. Routine pain assessment will be done at In addition, the type, route, effect and amount of analgesic done in this process will also be recorded. Response evaluation will follow. Response evaluation will follow. Hot application will be applied to every shoulder pain reported by the patients.
Arm Title
control group
Arm Type
No Intervention
Arm Description
First, an individual information form will be filled in for the control group patients who meet the sampling criteria. 0-2-4-8-12-24 after the patients come to the service after the surgery. Routine pain assessment will be done at In addition, the type, route, effect and amount of analgesic done in this process will also be recorded. Response evaluation will follow.
Intervention Type
Other
Intervention Name(s)
hot application
Intervention Description
a thermophore filled with hot water will be placed on the patient's shoulder according to the presence of shoulder pain and it will be ensured that he stays for 15 minutes.
Primary Outcome Measure Information:
Title
change of pain
Description
Numerical Pain Rating Scale (NRS) The form used by Williamson & Hoggart (2005) to assess pain, patients will be asked to select a number from 0 to 10 that best describes their current pain. 0 means no pain and 10 means severe pain. It will be scored as no pain (0), mild pain (1-3), moderate (4-7) and severe pain (8-10).
Time Frame
24 hours
Title
analgesic consumption
Description
analgesic consumption form
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Agreeing to participate in the research, Having undergone laparoscopic abdominal surgery Those who have no previous history of surgery Exclusion Criteria: Those who did not agree to participate in the research Those who have had previous abdominal surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derya Gezer
Phone
05076990081
Email
deryasahhin@hotmail.com
Facility Information:
Facility Name
Tarsus Universty
City
Mersin
State/Province
Tarsus
ZIP/Postal Code
33400
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DERYA GEZER
Phone
05076990081
Email
deryasahhin@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results about the effect of hot application on pain and analgesic use will be shared. however, personal information will not be shared.
Citations:
PubMed Identifier
1826624
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Links:
URL
https://fnur.stafpu.bu.edu.eg/Maternal%20and%20Newborn%20Health/1833/publications/Aziza%20Ibrahim%20Mohammed%20Hassan_B05121016_6.pdf
Description
Heating pads and early mobilization for reducing postoperative shoulder pain and enhancing recovery of women undergoing gynecological laparoscopic surgery
URL
http://dergipark.org.tr/tr/pub/hunhemsire/issue/7838/103252
Description
Ağrı kontrolünde farmakolojik olmayan yöntemler

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The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use

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