The Effect of Respiratory Exercise After Laparoscopic Surgery

NCT05624346 | Completed DMC

• 1 other identifier: 2022-SBB-0086
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery (LS) enables the patient to experience the desired result with smaller incisions in the postoperative period, more aesthetically, stress-free and less painful. This increases patient satisfaction and reduces morbidity and mortality. In the literature, it has been stated that respiratory exercises reduce the level of anxiety in different patient groups in the postoperative period and increase the quality of sleep and recovery. Among the duties and responsibilities of nurses working in surgical clinics are to provide breathing exercise training to patients in the preoperative period and to ensure that it is applied in the postoperative period. This study was planned to determine the effect of respiratory exercise applied to laparoscopic surgery patients on postoperative pain, anxiety, nausea-vomiting and respiratory parameters.

Conditions

Laparoscopic Surgery; Breathing Exercise

Keywords

Laparoscopic Surgery; Breathing Exercise; Pain; Anxiety; Postoperative period

Outcome Measures

Primary Outcomes (1)

• Measuring of anxiety

  The effect of breathing exercise in patients after laparoscopic surgery using by State and Trait Anxiety Scale. The State-Trait Anxiety Inventory is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  Between 1-6 hours and 24 hours after surgery

Secondary Outcomes (3)

• Respiratory parameters

  2nd, 6th, 12th and 24th hours after surgery

• Measuring the level of nausea-vomiting

  2nd, 4th, 6th, 12th and 24th hours after surgery

• Measuring the level of pain

  2nd, 6th, 12th and 24th hours after surgery

Study Arms (2)

Experimental Group

EXPERIMENTAL

After the operation, breathing exercises will be applied to the patients.

Other: Deep-Breathing Exercises

Control Group

NO INTERVENTION

There will be no intervention other than routine nursing care practices in the hospital.

Interventions

Deep-Breathing Exercises OTHER

In addition to routine care in the hospital, the patient will be taught pre-operative breathing exercises. After surgery the patients do deep-breathing exercises every hour.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Agreeing to participate in the study verbally and in writing,
• years and over,
• No neurological or psychological problems,
• Fluent in Turkish and able to communicate,
• No respiratory disease,
• Brought to the post-operative service,
• Planned cases,
• Patients who underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) under general anesthesia were included in the study.

You may not qualify if:

• Those who do not accept to participate in the study verbally or in writing,
• Not 18 years of age or older
• Having neurological or psychological problems,
• Those who do not speak Turkish and cannot communicate
• Having respiratory disease
• Transferred to the intensive care unit after surgery,
• Emergency and unplanned cases
• Cases that converted from laparoscopic surgery to open surgery under general anesthesia were not included in the study.

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

Bartin Hospital of State

Bartın, Merkez, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Suna UZUN, Msc. Student

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

• Elif KARAHAN, Assoc. Prof.

  Bartın Unıversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: Randomized controlled experimental research

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 22, 2022
• Study Start: September 26, 2022
• Primary Completion: August 22, 2023
• Study Completion: September 25, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)