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

NCT05532436 | Completed

• 1 other identifier: GBULUT
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy, Laparoscopic

Keywords

anxiety; breathing exercise; laparoscopic cholecystectomy; nurse; recovery quality; sleep quality

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Grup 1

EXPERIMENTAL

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. Introductory Information Form, State-Trait Anxiety Scale, Visual Comparative Sleep Scale and Recovery Quality-40 Questionnaire were used to collect data 1 day before surgery, on the day of surgery, on the 1st day, 15th and 30th days after surgery.

Other: Breath Exercise

Grup 2

NO INTERVENTION

Each data collection tool was collected as in the experimental group patients, but without breathing exercises. Only routine nursing care was given to the patients in the control group. The patients in the control group were given a breathing exercise brochure/booklet when they came to the control after the postoperative 30th day, and they were shown how the breathing exercises would be done correctly.

Interventions

Breath Exercise OTHER

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.

Grup 1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Gamze BULUT

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Gamze BULUT

  Ataturk Unıversty

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: August 20, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)