- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05283291
Directed Imagery Technique Applied to Patients Undergoing Lumbar Disc Herniation Surgery
The Effect of Directed Imagery Technique Applied to Patients Who Have Had Lumbar Disc Herniation Surgery on Patients' Pain, Anxiety, and Sleep Levels: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Patients in the control group; Nursing care will be applied according to the routine care protocol of the clinic where the research was conducted.
- Patients in the experimental group; In addition to the nursing care given according to the routine care protocol of the clinic where the research was conducted, the "imagery method" will be applied four times in total, once before the operation, once on the 1st day, 2nd day and 3rd day after the operation. It will be ensured that the patients to be imaged are in the supine or semifawler position in a comfortable way and listen to the audio recording with headphones.
Before the application, the patient will be told to listen to the audio recording with headphones at the most convenient time of the day for him, in an environment where he will not be disturbed by others, by putting his phone in airplane mode, after giving advance notice to avoid disturbing family members. Headphones will be provided for each patient by the researcher. In the first meeting, the voice recordings will be transferred to the phones of the individuals via the phone in the Neurosurgery Service. Communication with the patient will be provided in accordance with the pandemic rules. In the preoperative period, "Descriptive Information Form", "Operation-Specific Anxiety Scale", "Richard-Campbell Sleep Scale", "Visual Analog Scale (VAS)", "State Anxiety Scale" will be applied to the experimental and control groups before imagery is performed. After the interventions applied to the experimental group are completed, the scales will be re-administered to the individuals in the experimental and control groups.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kayseri, Turkey, 38030
- Eda Albayrak
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Those who will undergo lumbar disc hernia surgery
- Compliant with ASA 1 and 2 classification
- Preoperative hospitalizations
- Patients without cognitive clouding
- Patients who can speak Turkish
- Patients without hearing and vision problems will be included in the study.
Exclusion Criteria:
- Those over the age of eighty or under the age of 18
- Having a psychiatric disease and using medication
- Having trouble sleeping and taking medication
- Those who are classified as ASA 3 and above,
- Those who have laparoscopic surgery,
- Those with chronic pain, alcohol, drug and substance addiction,
- Oncological cases,
- Those with hearing, vision, speech and cognitive dysfunction,
- Those who do not speak Turkish,
- People with high anxiety who use anxiolytics
- Patients who do not accept the procedure will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: İmaginary group
Expert opinion for the scenario will be taken from a psychologist and a psychiatric nurse. The flow of the script; It will start with breathing exercises and continue with the safe place application, after affirming the functionality that is said while in a safe place in the mind, it will be in the form of waking up by turning to the body and returning to the present. Headphones will be provided for each patient by the researcher. In the first meeting, the voice recordings will be transferred to the phones of the individuals via the phone in the Neurosurgery Service. Communication with the patient will be provided in accordance with the pandemic rules. The audio recording will be played twice, in the evening before the operation and on the evening of the operation day. |
The sound recording will include a soothing light background music for approximately 30 minutes. Imagination will be practiced, starting with the patient's focusing his/her attention on his/her breath, relaxation, and relaxation with the suggestions given in the recording with the accompaniment of relaxing music. |
No Intervention: Control group
In the routine care applied to the patients, the vitals of the patients are followed, drug treatments are administered and the motor functions of the patients are monitored.
In addition, analgesics are routinely administered in the ward for pain and no attempt is made for sleep.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative Anxiety Scale
Time Frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of surgery day (Time 2)]
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The range of scores that can be taken from the scale is 10-50 points, and high scores reflect high anxiety.
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Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of surgery day (Time 2)]
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Richards Campbell Sleep Scale
Time Frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
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Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique.
A score of "0-25" from the scale indicates "very bad sleep" and a score of "76-100" indicates "very good sleep".
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Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
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Visual Analog Scale (VAS)
Time Frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
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"0" describes no pain, "100" describes the most unbearable pain.
A score of "0-30" indicates mild pain, a score of "31-60" indicates moderate pain, and a score of "61 and above" indicates severe pain.
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Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eda Albayrak, TC Erciyes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErciyesU-Albayrak-001
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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