- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06912750
4-7-8 Breathing and Teach-Back Method for Pain, Anxiety, and Sleep After Knee Surgery: A Clinical Trial
Effect of 4 7 8 Breathing Exercises With Teach Back Method on Pain Anxiety and Sleep Quality in Patients After Total Knee Arthroplasty: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 25050
- Erzurum Techical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who are conscious and oriented,
- Able to communicate,
- Age 65 and over,
- No cognitive-mental problems,
- Standard Mini Mental Test (SMMT) score of 24 and above,
- Have not attended a course on breathing exercises and yoga before,
- Patients who agree to participate in the study verbally and in writing
Exclusion Criteria:
- Unconscious,
- Unable to communicate,
- Under 65 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 4-7-8 Breathing Exercise with Teach-Back Method
|
In the experimental group, patients will be provided with information regarding the purpose and significance of the 4-7-8 breathing technique using the Teach-Back method one day before surgery. To confirm comprehension, patients will be asked to repeat the information. The exercise will be demonstrated in a one-on-one session using the Teach-Back method, and patients will be guided through practical application. Following the training, patients will be instructed to perform the exercise independently, with the researcher monitoring its correct implementation. Each patient will be given a "4-7-8 Breathing Exercise Application Guide," which outlines the exercise steps based on relevant literature. Before surgery, patients will complete the "Patient Information Form," the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI), and the Richards-Campbell Sleep Questionnaire (RCSQ). Postoperatively, the VAS and STAI will be administered both before (pre-test) and after |
|
No Intervention: Standard Postoperative Care
In the control group, patients will complete the "Patient Information Form," the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI), and the Richards-Campbell Sleep Questionnaire (RCSQ) before undergoing total knee arthroplasty, without any additional interventions beyond standard clinical protocols. Postoperatively, the VAS and STAI will be administered at the 6th, 12th, and 24th hours without any interventions. Following these assessments, patients will be asked to remain in a quiet and calm environment for 30 minutes. At the end of this period, the researcher will reassess pain and anxiety levels using the VAS and STAI, and the data will be collected. Additionally, at the 24th postoperative hour, the RCSQ will be administered, marking the conclusion of data collection for the control group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Richard Campbell Sleep Quality Scale
Time Frame: 24 hours
|
This scale evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep and the noise levels in the environment.
When filling out the scale, the person is asked to mark the appropriate option for each item on a chart consisting of 6 items, each item being between 0 and 100.
The scale is evaluated with the visual analog scale technique.
The score between "0-25" from the scale indicates very bad sleep, and the score between "76-100" indicates very good sleep.
The total score of the scale is evaluated based on the first 5 items.
The 6th item evaluates the noise level in the environment and is not included in the total score evaluation.
As a result, it is concluded that the sleep quality of the participants increases as the total score increases.
|
24 hours
|
|
State Anxiety Scale
Time Frame: 24 hours
|
The scale consists of 20 questions that measure state anxiety.
The "State Anxiety Scale (STAI FORM TX-I, DKO)" requires the individual to express how he/she feels at a certain moment and under certain conditions.
A minimum of 20 and a maximum of 80 points can be obtained from each subscale, with higher scores indicating a higher level of anxiety.
|
24 hours
|
|
Visual Comparison Scale
Time Frame: 24 hours
|
This scale, developed to determine the intensity of pain, is a 10 cm ruler scale with "No Pain" written on one end and "Unbearable Pain" on the other.
It consists of numbers divided into equal intervals of one cm between the starting point where there is no pain and the point marked by the patient.
In the evaluation of this scale, 0 = no pain, 1-4 = mild pain, 5-6 = moderate pain, 7-8 = severe pain and 10 = unbearable pain
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yasemin Erden, Assistant Professor, Erzurum Technical University Faculty of Helath Science
- Principal Investigator: Tülay Kılınç, Assistant Professor, Atatürk University Faculty of Nursing
- Principal Investigator: Zeynep Bal, Firat University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 02.16.23.01.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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