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Directed Imagery Technique Applied to Patients Undergoing Lumbar Disc Herniation Surgery

Primary Purpose

Intervertebral Disc Disorder Lumbar With Radiculopathy, Surgical or Other Invasive Procedure on Wrong Patient, Nurse-Patient Relations

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Directed Imagery Technique
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intervertebral Disc Disorder Lumbar With Radiculopathy focused on measuring Directed Imagery Technique, Herniated Disc, ache, anxiety, Sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Those who will undergo lumbar disc hernia surgery
  2. Compliant with ASA 1 and 2 classification
  3. Preoperative hospitalizations
  4. Patients without cognitive clouding
  5. Patients who can speak Turkish
  6. Patients without hearing and vision problems will be included in the study.

Exclusion Criteria:

  1. Those over the age of eighty or under the age of 18
  2. Having a psychiatric disease and using medication
  3. Having trouble sleeping and taking medication
  4. Those who are classified as ASA 3 and above,
  5. Those who have laparoscopic surgery,
  6. Those with chronic pain, alcohol, drug and substance addiction,
  7. Oncological cases,
  8. Those with hearing, vision, speech and cognitive dysfunction,
  9. Those who do not speak Turkish,
  10. People with high anxiety who use anxiolytics
  11. Patients who do not accept the procedure will not be included in the study.

Sites / Locations

  • Eda Albayrak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İmaginary group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Preoperative Anxiety Scale
The range of scores that can be taken from the scale is 10-50 points, and high scores reflect high anxiety.
Richards Campbell Sleep Scale
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".
Visual Analog Scale (VAS)
"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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2022
Last Updated
March 11, 2022
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05283291
Brief Title
Directed Imagery Technique Applied to Patients Undergoing Lumbar Disc Herniation Surgery
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Directed Imagery technique (YIT) is a set of stories that people create by first giving relaxation exercises and then visualizing the symbols given by the practitioner. Guided imagery is based on the understanding that the body and mind are interconnected and that the mind can affect the body. In directed imagery, the person's thoughts and imagination are focused and directed to a specific goal by the practitioner, usually through a sound recording. The directed imagery technique can be effective in solving problems such as pain, stress, fatigue, and anxiety in nursing care.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Disorder Lumbar With Radiculopathy, Surgical or Other Invasive Procedure on Wrong Patient, Nurse-Patient Relations
Keywords
Directed Imagery Technique, Herniated Disc, ache, anxiety, Sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
İmaginary group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Directed Imagery Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preoperative Anxiety Scale
Description
The range of scores that can be taken from the scale is 10-50 points, and high scores reflect high anxiety.
Time Frame
Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of surgery day (Time 2)]
Title
Richards Campbell Sleep Scale
Description
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".
Time Frame
Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
Title
Visual Analog Scale (VAS)
Description
"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.
Time Frame
Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda Albayrak
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eda Albayrak
City
Kayseri
ZIP/Postal Code
38030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Directed Imagery Technique Applied to Patients Undergoing Lumbar Disc Herniation Surgery

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