Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05532436
Other study ID # GBULUT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date August 20, 2022

Study information

Verified date September 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to determine the effect of breath exercise on post-operative anxiety level, sleep and recovery quality after laparoscopic cholecystectomy surger. This was a randomized controlled experimental study. The sample comprised 115 patients who underwent laparoscopic cholecystectomy (control:57; experimental:58). One day before the operation, the participants in the experimental group were given breathing exercise training, and they were applied 5 times a day for 10 repetitions until the 30th day after the operation.


Description:

Surgical interventions are one of the most important experiences in an individual's life and are used to improve the quality of life, to treat diseases and to improve health. Cholelithiasis is one of the most common surgical procedures that can be treated with laparoscopic cholecystectomy. Although laparoscopic surgery is a minimally invasive surgical procedure, it is expected that patients who will receive general anesthesia have an increased level of anxiety, feel pain and disrupt their sleep patterns. The body's stress response is an expected process in coping with the problems that may develop in the post-operative period, adapting to the new situation and accelerating the recovery. However, when stressors and the response to these stressors are excessive and continuous, the healing process is adversely affected. It has been reported in the literature that patients with high anxiety levels before and after surgical intervention have a higher rate of medical complications and adversely affect wound healing. Sleep-related problems are one of the specific consequences of the stress response to surgery. In the literature, it has been stated that patients experience sleep problems after surgical intervention and their sleep quality is adversely affected. This situation may negatively affect the quality of life of patients, as well as increase the rate of morbidity and mortality. On the other hand, the good sleep quality of the patients affects the healing process positively and ensures early budding. In this context, well-planned patient education and nursing care management before surgery will be effective in increasing the sleep pattern and quality of patients. Oxygenation of the traumatized tissues must be sufficient for wound healing in the postoperative incisional area. This oxygen requirement is met by effective ventilation. However, after surgery, patients have difficulty in breathing deeply due to reasons such as pain and limitation of movement. Studies have shown that the practice of planned breathing exercises reduces stress in patients in the pre- and post-operative period, provides calming, and has a positive effect on the level of pain and wound healing. In this respect, planned patient education and care to be given to patients before surgery is very effective in preventing complications related to surgical intervention. One of the basic duties of surgical nurses is to teach and apply deep breathing and coughing exercises to the patient in pre-operative patient education. It is very important to explain the importance of these exercises to the patient and the effects of performing them at regular intervals on the quality of recovery. However, studies have drawn attention to the fact that the rates of teaching and applying deep breathing exercises to patients are not at the desired level. Non-pharmacological applications have been widely used in recent years to improve the quality of recovery of patients after laparoscopic cholecystectomy. It has been stated in studies that deep breathing exercises, which is one of the non-pharmacological methods, reduce the anxiety level in different patient groups and increase the quality of sleep and recovery in the postoperative period. After laparoscopic cholecystectomy, the effects on many parameters such as pain, nausea-vomiting, anxiety, vital signs, early discharge, comfort, sleep and early mobilization were investigated by having patients undergo many non-pharmacological nursing practices such as cuppressor, massage, breathing exercise, music, gum chewing, and virtual reality. However, no research has been found that examines the effect of deep breathing exercise, which is planned after laparoscopic cholecystectomy, on the quality of recovery. In this context, this study was planned to determine the effect of deep breathing exercise applied to patients with laparoscopic cholecystectomy on the level of anxiety, sleep and recovery quality after surgery. This study was conducted to determine the effect of breathing exercise on postoperative anxiety level, sleep and recovery quality in laparoscopic cholecystectomy surger. This was a randomized controlled experimental study. The sample comprised 188 patients who underwent laparoscopic cholecystectomy (control:57; experimental:58).


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date August 20, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 18 years and over, Having undergone laparoscopic cholecystectomy surgery with general anesthesia, They do not have physical/mental disabilities, limitations and diseases that would prevent them from doing breathing exercises (such as the use of drugs that affect breathing and requiring oxygen therapy, etc.) Cognitive level scales are suitable for application, Patients with video phones and no communication problems were included in the study. Exclusion Criteria: Postoperative hemodynamic values unstable, Developing any complications such as severe bleeding, nausea, vomiting after surgery, Leaving work voluntarily, Patients with acute or chronic lung disease were not included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Breath Exercise
It was provided by the researcher that the patients performed 5 repetitions of 10 breathing exercises every 3 hours a day, between 09:00am and 21:00pm, 1 day before the surgery, on the day of surgery and on the first day after surgery.

Locations

Country Name City State
Turkey Gamze BULUT Erzurum Palandöken

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The State-Trait Anxiety Inventory (STAI) It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety). 1 day before surgery
Primary The State Anxiety Inventory (SAI) It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety). On the 1 day of surgery
Primary The State Anxiety Inventory (SAI) It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety). 1st day after surgery
Primary The State Anxiety Inventory (SAI) It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety). 15st day after surgery
Primary The State Anxiety Inventory (SAI) It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety). 30st day after surgery
Primary Visual Analog Sleep Scale (VASS) The VASS was developed by Verran and Snyder-Halpern in 1988 to evaluate the sleep quality of patients and healthy individuals. The Turkish validity reliability studywas performed by Çetinkaya and Karabulut in 2016. The Turkish form of the scale was created from 10 items without sub-dimensions and some items were removed, unlike the original. Each item in the scale is evaluated using the visual comparison technique on a chart from 0(at the left end) to 100 (at the right end). The Turkish form of thescale produces a score between 0 and 1000 under the title of sleepquality. The increase in the score obtained from the scale indicates that the quality of sleep decreases. 1 day before surgery
Primary Visual Analog Sleep Scale (VASS) The VASS was developed by Verran and Snyder-Halpern in 1988 to evaluate the sleep quality of patients and healthy individuals. The Turkish validity reliability studywas performed by Çetinkaya and Karabulut in 2016. The Turkish form of the scale was created from 10 items without sub-dimensions and some items were removed, unlike the original. Each item in the scale is evaluated using the visual comparison technique on a chart from 0(at the left end) to 100 (at the right end). The Turkish form of thescale produces a score between 0 and 1000 under the title of sleepquality. The increase in the score obtained from the scale indicates that the quality of sleep decreases. On the 1 day of surgery
Primary Visual Analog Sleep Scale (VASS) The VASS was developed by Verran and Snyder-Halpern in 1988 to evaluate the sleep quality of patients and healthy individuals. The Turkish validity reliability studywas performed by Çetinkaya and Karabulut in 2016. The Turkish form of the scale was created from 10 items without sub-dimensions and some items were removed, unlike the original. Each item in the scale is evaluated using the visual comparison technique on a chart from 0(at the left end) to 100 (at the right end). The Turkish form of thescale produces a score between 0 and 1000 under the title of sleepquality. The increase in the score obtained from the scale indicates that the quality of sleep decreases. 1st day after surgery
Primary Visual Analog Sleep Scale (VASS) The VASS was developed by Verran and Snyder-Halpern in 1988 to evaluate the sleep quality of patients and healthy individuals. The Turkish validity reliability studywas performed by Çetinkaya and Karabulut in 2016. The Turkish form of the scale was created from 10 items without sub-dimensions and some items were removed, unlike the original. Each item in the scale is evaluated using the visual comparison technique on a chart from 0(at the left end) to 100 (at the right end). The Turkish form of thescale produces a score between 0 and 1000 under the title of sleepquality. The increase in the score obtained from the scale indicates that the quality of sleep decreases. 15st day after surgery
Primary Visual Analog Sleep Scale (VASS) The VASS was developed by Verran and Snyder-Halpern in 1988 to evaluate the sleep quality of patients and healthy individuals. The Turkish validity reliability studywas performed by Çetinkaya and Karabulut in 2016. The Turkish form of the scale was created from 10 items without sub-dimensions and some items were removed, unlike the original. Each item in the scale is evaluated using the visual comparison technique on a chart from 0(at the left end) to 100 (at the right end). The Turkish form of thescale produces a score between 0 and 1000 under the title of sleepquality. The increase in the score obtained from the scale indicates that the quality of sleep decreases. 30st day after surgery
Primary Quality of Recovery Scale (QoR-40) The QoR-40 questionnaire, defined by Myles and colleagues in 2000, is a self-rating questionnaire used to evaluate patients' postoperative recovery quality and health status in the early postoperative stages. The QoR-40 consists of two parts, 40 items across five QoR dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item was rated on a five-point Likert scale, ranging from one (worst) to five (best), where 1 = none of the time, 2 = some of the time, 3 = usually, 4 = most of the time, and 5 = all the time. The total score ranges from 40 (worst recovery quality) to 200 (best recovery quality). 1 day before surgery
Primary Quality of Recovery Scale (QoR-40) The QoR-40 questionnaire, defined by Myles and colleagues in 2000, is a self-rating questionnaire used to evaluate patients' postoperative recovery quality and health status in the early postoperative stages. The QoR-40 consists of two parts, 40 items across five QoR dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item was rated on a five-point Likert scale, ranging from one (worst) to five (best), where 1 = none of the time, 2 = some of the time, 3 = usually, 4 = most of the time, and 5 = all the time. The total score ranges from 40 (worst recovery quality) to 200 (best recovery quality). 1st day after surgery
Primary Quality of Recovery Scale (QoR-40) The QoR-40 questionnaire, defined by Myles and colleagues in 2000, is a self-rating questionnaire used to evaluate patients' postoperative recovery quality and health status in the early postoperative stages. The QoR-40 consists of two parts, 40 items across five QoR dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item was rated on a five-point Likert scale, ranging from one (worst) to five (best), where 1 = none of the time, 2 = some of the time, 3 = usually, 4 = most of the time, and 5 = all the time. The total score ranges from 40 (worst recovery quality) to 200 (best recovery quality). 15st day after surgery
Primary Quality of Recovery Scale (QoR-40) The QoR-40 questionnaire, defined by Myles and colleagues in 2000, is a self-rating questionnaire used to evaluate patients' postoperative recovery quality and health status in the early postoperative stages. The QoR-40 consists of two parts, 40 items across five QoR dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item was rated on a five-point Likert scale, ranging from one (worst) to five (best), where 1 = none of the time, 2 = some of the time, 3 = usually, 4 = most of the time, and 5 = all the time. The total score ranges from 40 (worst recovery quality) to 200 (best recovery quality). 30st day after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT06074679 - Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis N/A
Completed NCT02575443 - Neuromuscular Block and Anesthetic Depth Monitoring N/A
Completed NCT04745273 - Interaction Between Tramadol and Ondansetron Phase 4
Not yet recruiting NCT03018964 - Solo Single Incision Laparoscopic Cholecystectomy N/A
Completed NCT01523886 - The Muscle Relaxation-study Phase 4
Completed NCT05214157 - Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT N/A
Completed NCT03586791 - Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia N/A
Completed NCT03794271 - Effect of Pupilometer Guided Analgesia on Postoperative Pain N/A
Completed NCT02185716 - Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery Phase 4
Not yet recruiting NCT06193837 - Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)
Recruiting NCT05728463 - Single Incision Laparoscopic Cholecystectomy Compared With Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study N/A
Completed NCT04254237 - Trocar Site Hernia After Laparoscopic Cholecystectomy, Supra Versus Infraumbilical Incision for Umbilical Trocar Entry N/A
Completed NCT00892879 - A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy Phase 3
Completed NCT00848146 - NOTES-Assisted Laparoscopic Cholecystectomy Surgery N/A
Not yet recruiting NCT02978989 - Solo and Non-solo Approach for Laparoscopic Cholecystectomy N/A
Completed NCT05728073 - Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?
Completed NCT03241875 - Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy Phase 4
Completed NCT00288899 - Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program Phase 1
Completed NCT03258177 - Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience) N/A
Recruiting NCT01094379 - A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy N/A