Clinical trial NCT05532436: The Effect of Breath Exercise on Patients' Post-Operative Anxiety Level, Sleep and Recovery Quality
Official title: The Effect of Breath Exercise on Post-Operative Anxiety Level, Sleep and Recovery Quality in Laparoscopic Cholecystectomy Surgery:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Keywords: anxiety
breathing exercise
laparoscopic cholecystectomy
nurse
recovery quality
sleep quality
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 1 day before surgery
measure: The State Anxiety Inventory (SAI)
timeFrame: On the 1 day of surgery
measure: The State Anxiety Inventory (SAI)
timeFrame: 1st day after surgery
measure: The State Anxiety Inventory (SAI)
timeFrame: 15st day after surgery
measure: The State Anxiety Inventory (SAI)
timeFrame: 30st day after surgery
measure: Visual Analog Sleep Scale (VASS)
timeFrame: 1 day before surgery
measure: Visual Analog Sleep Scale (VASS)
timeFrame: On the 1 day of surgery
measure: Visual Analog Sleep Scale (VASS)
timeFrame: 1st day after surgery
measure: Visual Analog Sleep Scale (VASS)
timeFrame: 15st day after surgery
measure: Visual Analog Sleep Scale (VASS)
timeFrame: 30st day after surgery
measure: Quality of Recovery Scale (QoR-40)
timeFrame: 1 day before surgery
measure: Quality of Recovery Scale (QoR-40)
timeFrame: 1st day after surgery
measure: Quality of Recovery Scale (QoR-40)
timeFrame: 15st day after surgery
measure: Quality of Recovery Scale (QoR-40)
timeFrame: 30st day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Gamze BULUT
state: Palandöken
Study officials:
affiliation: Ataturk Unıversty
name: Gamze BULUT
role: PRINCIPAL_INVESTIGATOR
References: