Intervertebral Disc Disorder Lumbar With RadiculopathyNCT05283291
Directed Imagery Technique Applied to Patients Undergoing Lumbar Disc Herniation Surgery
A study testing Directed Imagery Technique in people with Intervertebral Disc Disorder Lumbar With Radiculopathy and Surgical or Other Invasive Procedure on Wrong Patient, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervertebral Disc Disorder Lumbar With Radiculopathy, Surgical or Other Invasive Procedure on Wrong Patient, Nurse-Patient Relations
- What is being tested?
- Directed Imagery Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2022to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Intervertebral Disc Disorder Lumbar With Radiculopathy, Surgical or Other Invasive Procedure on Wrong Patient, Nurse-Patient Relations
- Being tested
- Directed Imagery Technique
- Keywords
- Directed Imagery Technique, Herniated Disc, ache, anxiety, Sleep
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directed Imagery TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| İmaginary group | Experimental | 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. Receives: Behavioral: Directed Imagery Technique |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Scale
The range of scores that can be taken from the scale is 10-50 points, and high scores reflect high anxiety.
Measured: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of surgery day (Time 2)]
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".
Measured: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
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.
Measured: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start8 Feb 2022
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc Disorder Lumbar With RadiculopathyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Albayrak, TC Erciyes University
- Investigators
- Eda Albayrak, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283291
- Sponsor's protocol ID
- ErciyesU-Albayrak-001
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05283291
- Acronym / sponsor ID
- ErciyesU-Albayrak-001
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İmaginary group | Experimental | Behavioral: Directed Imagery TechniqueExpert 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directed Imagery TechniqueThe 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. | Behavioural | İmaginary group |
Primary outcome
Preoperative Anxiety Scale
Time frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of surgery day (Time 2)]
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
Time frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
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)
Time frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of the day of surgery (Duration 2), postoperative (Duration 3)
"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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda Albayrak principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directed Imagery Technique in people with Intervertebral Disc Disorder Lumbar With Radiculopathy and Surgical or Other Invasive Procedure on Wrong Patient, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Scale (time frame: Change: [Time Frame: 3 days: Preoperative assessment (Time 1), morning of surgery day (Time 2)]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.