The Impact of Breath Exercise Training on Postoperative Pain, Anxiety, and Nausea-Vomiting in General Surgery Patients

NCT06546514 | Completed

• 1 other identifier: Gamze
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to determine the effect of breath exercise on post-operative anxiety level, pain, and nausea-vomiting after general surgery. This was a randomized, controlled experimental study. The sample comprised 149 patients who underwent laparoscopic cholecystectomy and hernia (control:73; experimental:76). 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

Postoperative Pain, Acute; Postoperative Nausea and Vomiting; Patient Relations, Nurse

Keywords

Postoperative Pain; Anxiety; Nausea-Vomiting; Nurse; Breathing Exercise; General Surgery

Outcome Measures

Primary Outcomes (14)

• The State-Trait Anxiety Inventory (STAI

  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)

  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).

  On the day of surgery

• The State Anxiety Inventory (SAI)

  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).

  1st day after surgery

• The State Anxiety Inventory (SAI)

  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).

  15st day after surgery

• The State Anxiety Inventory (SAI)

  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).

  30st day after surgery

• Rhodes Nausea and Vomiting Index

  The index's alpha internal consistency coefficient is 0.98, and the alpha internal consistency coefficients for the subgroups range from 0.83 to 0.99. The adaptation of the Rhodes Nausea and Vomiting Index to the Turkish population was done by Genç (2010). In Genç's (2010) adaptation, the internal consistency coefficient was found to be 0.95, with the alpha internal consistency for the subgroups ranging from 0.81 to 0.95. In scoring the "Nausea and Vomiting Index," items 1, 3, 6, and 7 are reverse scored. For each response, 4 indicates the highest level of distress, and 0 indicates the lowest level of distress. The patient's nausea and vomiting experiences for each of the 8 items are summed. The highest possible score is 32, indicating the most severe symptom occurrence.

  1 day before surgery

• Rhodes Nausea and Vomiting Index

  The index's alpha internal consistency coefficient is 0.98, and the alpha internal consistency coefficients for the subgroups range from 0.83 to 0.99. The adaptation of the Rhodes Nausea and Vomiting Index to the Turkish population was done by Genç (2010). In Genç's (2010) adaptation, the internal consistency coefficient was found to be 0.95, with the alpha internal consistency for the subgroups ranging from 0.81 to 0.95. In scoring the "Nausea and Vomiting Index," items 1, 3, 6, and 7 are reverse scored. For each response, 4 indicates the highest level of distress, and 0 indicates the lowest level of distress. The patient's nausea and vomiting experiences for each of the 8 items are summed. The highest possible score is 32, indicating the most severe symptom occurrence.

  1st day after surgery

• Rhodes Nausea and Vomiting Index

  The index's alpha internal consistency coefficient is 0.98, and the alpha internal consistency coefficients for the subgroups range from 0.83 to 0.99. The adaptation of the Rhodes Nausea and Vomiting Index to the Turkish population was done by Genç (2010). In Genç's (2010) adaptation, the internal consistency coefficient was found to be 0.95, with the alpha internal consistency for the subgroups ranging from 0.81 to 0.95. In scoring the "Nausea and Vomiting Index," items 1, 3, 6, and 7 are reverse scored. For each response, 4 indicates the highest level of distress, and 0 indicates the lowest level of distress. The patient's nausea and vomiting experiences for each of the 8 items are summed. The highest possible score is 32, indicating the most severe symptom occurrence.

  15st day after surgery

• Rhodes Nausea and Vomiting Index

  The index's alpha internal consistency coefficient is 0.98, and the alpha internal consistency coefficients for the subgroups range from 0.83 to 0.99. The adaptation of the Rhodes Nausea and Vomiting Index to the Turkish population was done by Genç (2010). In Genç's (2010) adaptation, the internal consistency coefficient was found to be 0.95, with the alpha internal consistency for the subgroups ranging from 0.81 to 0.95. In scoring the "Nausea and Vomiting Index," items 1, 3, 6, and 7 are reverse scored. For each response, 4 indicates the highest level of distress, and 0 indicates the lowest level of distress. The patient's nausea and vomiting experiences for each of the 8 items are summed. The highest possible score is 32, indicating the most severe symptom occurrence.

  30st day after surgery

• Brief Pain Inventory

  The Turkish validity and reliability study was conducted by Dicle et al. The Brief Pain Inventory, which has high validity and reliability in different patient groups, has been translated into various languages. This short, simple, and understandable inventory consists of seven items related to the severity of pain and the extent to which pain interferes with daily activities. The pain severity measurements include the worst, least, average, and current pain over the last 24 hours. Pain severity is measured using a numerical pain scale (0 = no pain, 10 = unbearable pain). The dimensions of pain expressed by the individual measure the general activity status, emotional status, relationships with others, walking ability, exercise, sleep, and enjoyment of life due to pain over the past 24 hours. The Cronbach's alpha coefficient was found to be 0.79 for pain severity and 0.80 for the impact of pain.

  1 day before surgery

• Brief Pain Inventory

  The Turkish validity and reliability study was conducted by Dicle et al. The Brief Pain Inventory, which has high validity and reliability in different patient groups, has been translated into various languages. This short, simple, and understandable inventory consists of seven items related to the severity of pain and the extent to which pain interferes with daily activities. The pain severity measurements include the worst, least, average, and current pain over the last 24 hours. Pain severity is measured using a numerical pain scale (0 = no pain, 10 = unbearable pain). The dimensions of pain expressed by the individual measure the general activity status, emotional status, relationships with others, walking ability, exercise, sleep, and enjoyment of life due to pain over the past 24 hours. The Cronbach's alpha coefficient was found to be 0.79 for pain severity and 0.80 for the impact of pain.

  On the day of surgery

• Brief Pain Inventory

  The Turkish validity and reliability study was conducted by Dicle et al. The Brief Pain Inventory, which has high validity and reliability in different patient groups, has been translated into various languages. This short, simple, and understandable inventory consists of seven items related to the severity of pain and the extent to which pain interferes with daily activities. The pain severity measurements include the worst, least, average, and current pain over the last 24 hours. Pain severity is measured using a numerical pain scale (0 = no pain, 10 = unbearable pain). The dimensions of pain expressed by the individual measure the general activity status, emotional status, relationships with others, walking ability, exercise, sleep, and enjoyment of life due to pain over the past 24 hours. The Cronbach's alpha coefficient was found to be 0.79 for pain severity and 0.80 for the impact of pain.

  1st day after surgery

• Brief Pain Inventory

  The Turkish validity and reliability study was conducted by Dicle et al. The Brief Pain Inventory, which has high validity and reliability in different patient groups, has been translated into various languages. This short, simple, and understandable inventory consists of seven items related to the severity of pain and the extent to which pain interferes with daily activities. The pain severity measurements include the worst, least, average, and current pain over the last 24 hours. Pain severity is measured using a numerical pain scale (0 = no pain, 10 = unbearable pain). The dimensions of pain expressed by the individual measure the general activity status, emotional status, relationships with others, walking ability, exercise, sleep, and enjoyment of life due to pain over the past 24 hours. The Cronbach's alpha coefficient was found to be 0.79 for pain severity and 0.80 for the impact of pain.

  15st day after surgery

• Brief Pain Inventory

  The Turkish validity and reliability study was conducted by Dicle et al. The Brief Pain Inventory, which has high validity and reliability in different patient groups, has been translated into various languages. This short, simple, and understandable inventory consists of seven items related to the severity of pain and the extent to which pain interferes with daily activities. The pain severity measurements include the worst, least, average, and current pain over the last 24 hours. Pain severity is measured using a numerical pain scale (0 = no pain, 10 = unbearable pain). The dimensions of pain expressed by the individual measure the general activity status, emotional status, relationships with others, walking ability, exercise, sleep, and enjoyment of life due to pain over the past 24 hours. The Cronbach's alpha coefficient was found to be 0.79 for pain severity and 0.80 for the impact of pain.

  30st day after surgery

Study Arms (2)

Grup 1

EXPERIMENTAL

the group that performed breathing exercises

Other: Breath Exercise

Grup 2

NO INTERVENTION

the group that did not perform breathing exercises

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 general surgery with general anaesthesia. They do not have physical/mental disabilities, limitations and diseases that would prevent them from 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

Pain, Postoperative; Postoperative Nausea and Vomiting; Anxiety Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gamze BULUT ÖZLÜ

  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 Investigator

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: August 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)