Breathing Exercise Application in Patients With Gynecological Cancer.

NCT06777225 | Enrolling By Invitation

• 1 other identifier: CAKU-HEM-DG-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effects of breathing exercises on nausea, vomiting and anxiety levels in patients with gynecological cancer.

Conditions

Gynecological Cancer

Keywords

nausea; vomiting; gynecological canser; anxiety

Outcome Measures

Primary Outcomes (3)

• The effect of breathing exercise on nausea, vomiting and anxiety in patients with gynecological cancer receiving chemotherapy: Randomized Controlled Study.

  It is planned to be performed in Ankara Etlik City Hospital Adult Outpatient Chemotherapy Unit. The universe will consist of individuals who have been diagnosed with gynecological cancer in the relevant institution, will start their first course of chemotherapy, have stage 1-2-3 cancer, will receive 3 courses of chemotherapy at 21-day intervals, volunteer for the study, are 18 years of age and older, and are literate. In this study, the sample size was calculated with 95% theoretical power using the "G. Power-3.1.9.2" program before data collection. In order to determine whether there was a difference between the experimental and control groups in terms of nausea, vomiting and anxiety due to the breathing exercise applied to gynecological cancer patients receiving chemotherapy, an independent sample t-test was performed based on the two-sided Wilcoxon-Mann-Whitney test for 1:1 group allocation (Faul, 2007). For this reason, Kareem and Afiyanti's studies were taken as reference (Kareem

  20 week

• Effect of breathing exercise on nausea, vomiting and anxiety in gynecological cancer patients receiving chemotherapy: A Randomized Controlled Trial.

  Beck Anxiety Inventory A 21-question inventory developed by Dr. Aaron T. Beck was used. The reliability and validity of the Beck Depression Inventory (BDI), which is used to measure the severity of depression, was performed in our country by N. Hisli in 1989. (Cronbach's alpha value was calculated as 0.85). Each question takes a value between 0-3 points. When evaluating the results; 0-10 points are normal; 11-16 points are mild mood disorder; 17-20 points are borderline clinical depression; 21-30 points are moderate depression; 31-40 points are severe depression and over 40 points are very severe depression (Çiçekçe et al, 2023).

  20 week

• Effect of breathing exercise on nausea, vomiting and anxiety in gynecological cancer patients receiving chemotherapy: A Randomized Controlled Trial.

  Rhodes Nausea Vomiting and Retching Scale The scale was developed by Rhodes and McDaniel (1999), and its Turkish validity and reliability were made by Fatma Genç and Mehtap Tan. The scale, which evaluates the number and severity of nausea-vomiting-retching in the last 24 hours, consists of eight items. The scale has three sub-dimensions: Symptom Experience, Symptom Formation and Symptom Distress. The responses to the items on the five-point Likert-type scale are scored as 0 = minimum 22 distress level, 4 = maximum distress level. When evaluating the scores, items 1, 3, 6 and 7 are reversed. The highest score that can be obtained from the scale is 32, and higher scores mean that nausea-vomiting symptoms have increased in patients (Odabaşı et al, 2021).

  20 week

Study Arms (2)

experimental group

EXPERIMENTAL

The patient was given detailed information about the research and intervention, and written consent was obtained with an informed consent form. The patient's information was obtained through a diagnostic information form containing sociodemographic information. 1st, 2nd, 3rd Cycle (The following steps were followed.) The Rhodes Nausea Vomiting and Retching Index (BCI), Beck Anxiety Scale and VAS pain scale were applied and evaluated by the researcher. The patient was directed to the room determined by the nurse in the outpatient treatment unit. Breathing exercises were applied to the patient. The patient's chemotherapy infusion was started. After the patient's chemotherapy was completed, breathing exercises were applied again. The post-test was applied. Note: The satisfaction survey was evaluated only after the 3rd cycle.

Other: breathing exercises; Other: scale; Other: scala

control group

OTHER

The patient was given detailed information about the research and intervention, and written consent was obtained with an informed consent form. The patient's information was obtained through a diagnostic information form containing sociodemographic information. 1st, 2nd, 3rd Course (The following steps were followed.) The researcher applied the Rhodes Nausea Vomiting and Retching Index (BCOI), Beck Anxiety Scale and VAS pain scale as a pre-test and evaluated the patient. The patient was directed to the room determined by the nurse in the outpatient treatment unit. The patient's chemotherapy was started. The post-test was applied after the chemotherapy was completed.

Other: scale; Other: scala

Interventions

breathing exercises OTHER

This study is to examine the effects of breathing exercises on nausea, vomiting and anxiety levels in patients with gynecological cancer. 1 Exercise: * Find a quiet, calm and comfortable place for yourself. * Lie on your back in a comfortable place (flat surface, bed or couch) and bend your knees or sit in a comfortable place (chair or armchair). * Close your eyes. * Place your left hand on your belly and your right hand on your chest. * Take a deep breath through your nose for 4 seconds. * Feel your hand on your belly rise and your belly swell as you breathe in. * Make sure your chest is not swollen. * Hold your breath for 4 seconds. Breathe out in 4 seconds. * Do this 10 times every day, morning and evening, 3 times.

experimental group

scale OTHER

The patient received standard nursing care and the scale was applied after the intervention. The 21-question inventory developed by Dr. Aaron T. Beck was used. The reliability and validity of the Beck Depression Inventory (BDI), which is used to measure the severity of depression, was performed in our country by N. Hisli in 1989. (Cronbach's alpha value was calculated as 0.85). Each question takes a value between 0-3 points. When evaluating the results; 0-10 points are normal; 11-16 points are mild mood disorder; 17-20 points are borderline clinical depression; 21-30 points are moderate depression; 31-40 points are severe depression and over 40 points are very severe depression (Çiçekçe et al, 2023).

Also known as: Beck anxiety scale

control group; experimental group

scala OTHER

The scale was developed by Rhodes and McDaniel (1999), and its Turkish validity and reliability were carried out by Fatma Genç and Mehtap Tan. The scale, which evaluates the number and severity of nausea-vomiting-retching episodes in the last 24 hours, consists of eight items. The scale has three sub-dimensions: Symptom Experience, Symptom Formation, and Symptom Distress. The responses to the items on the five-point Likert-type scale are scored as 0 = minimum 22 distress level, 4 = maximum distress level. When evaluating the scores, items 1, 3, 6, and 7 are reversed. The highest score that can be obtained from the scale is 32, and higher scores mean that nausea-vomiting symptoms have increased in patients (Odabaşı et al, 2021).

Also known as: rhodes nausea and vomiting scale

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patients over 18 years old 1st cycle chemotherapy literate stage1-2-3
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old.
• Stage 1-2-3.
• Being literate.
• Having volunteer patients.
• Being diagnosed with gynecological cancer.
• Being a female patient receiving chemotherapy for the first time.
• Not smoking or consuming alcohol.
• Will receive 3 cycles of chemotherapy, 21 days apart.
• Not having a psychiatric diagnosis.

You may not qualify if:

• Stage 4.
• Those who have been diagnosed with cancer but have not received treatment and cannot complete the cure.
• Those with communication and psychiatric problems.
• Those who do not know how to read, write and speak Turkish.

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Etlik şehir hastanesi

Ankara, Yenimahalle, 06600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nausea; Vomiting; Anxiety Disorders

Interventions

Breathing Exercises; Weights and Measures

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Didem Gül,graduate student

  Çankırı Karatekin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It will be checked whether there is a difference between the experimental and control groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: It is a randomized controlled study. It includes an experimental and a control group.

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 15, 2025
• Study Start: December 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)