Clinical trial NCT06645457: The Effect of Stress Ball and 4-7-8 Breathing Technique on Fear, Anxiety and Physiological Parameters
Official title: The Effect of Stress Ball and 4-7-8 Breathing Technique on Pre-Procedure Fear, Anxiety and Physiological Parameters in Elderly Patients Undergoing Endoscopy: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Breathing Exercises
Cognitive Therapy
Stress
Anxiety
Physiological Parameters
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aimed to examine the effects of two different applications (stress ball and 4-7-8 breathing technique) before Upper GI Endoscopy on patients' fear, anxiety and physiological parameters before the procedure.

The study as a single-blind, pre-test and post-test experimental study.

Detailed description: Due to the procedures involved, endoscopy patients experience high levels of fear and anxiety. Fear and anxiety may activate the patient's autonomic nervous system, causing increased sweating, heart rate, blood pressure and respiratory rate, and complications related to the procedure. Reducing fear and anxiety and making the patient feel relaxed not only prevents possible harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to examine the effects of stress ball exercise and 4-7-8 breathing technique on the fear, anxiety and vital signs of patients who will undergo Upper Gastrointestinal (GI) endoscopy.

Eligibility criteria: Inclusion Criteria:

1. Upper GI Endoscopy will be performed for the first time,
2. American Society of Anesthesiologists (ASA) Status I-II
3. Those over 18 years of age
4. Participates in the research voluntarily and is willing to cooperate.
5. No visual impairment, hearing impairment or communication problem,
6. Not having a psychiatric diagnosis and not using anxiolytic, hypnotic or sedative drugs

Exclusion Criteria:

1. Those diagnosed with severe respiratory failure
2. Those who have health problems in the hand, wrist or arm area that prevent squeezing the stress ball.
3. Using psychiatric medication (antipsychotic, antidepressant, anxiolytic, sedative, etc.
4. Anyone who wishes to leave the research at any stage of the research, with his or her own initiative.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
measure: State-Trait Anxiety İnventory
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
Secondary outcomes:
measure: systolic blood pressure (mm/Hg)
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
measure: diastolic blood pressure (mm/Hg)
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
measure: SpO2-peripheral oxygen saturation (%)
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
measure: Respiratory rate (minute value)
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
measure: heart rate (minute value)
timeFrame: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mehtap ÇULLU
Study officials:
affiliation: Kafkas Üniversity
name: Ayşe Gül Parlak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Üniversity
name: Mehtap Çullu, PhD
role: STUDY_CHAIR
affiliation: muğla provincial directorate of national education
name: Zeliha Özkaraca, MSc
role: STUDY_CHAIR
References: