The Effect of Breath Exercise on Patients' Post-Operative Anxiety Level, Sleep and Recovery Quality

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

The Effect of Breath Exercise on Post-Operative Anxiety Level, Sleep and Recovery Quality in Laparoscopic Cholecystectomy Surgery:A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532436
• Other study ID #: GBULUT
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Cholecystectomy, Laparoscopic

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