Back to resultsThe Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery. (NIRS)
Primary Purpose
Lumbar Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ekspressive touch
Music
Sponsored by
About this trial
This is an interventional supportive care trial for Lumbar Disc Herniation focused on measuring Nursing, Touch, Music, Pain, Near-İnfrared Spectroscopy
Eligibility Criteria
Inclusion Criteria:
- Agreeing to participate in the research,
- General anesthesia applied,
- Patients with the same type of treatment protocol,
- Verbal pain score with at least 4,
- Patients with a Ramsay sedation Scale score of 3 and below,
- Without a chronic disease,
- Without a disease (AVM, blockage of brain vessels, etc.) that will affect brain oxygenation,
- Who has not been diagnosed with any psychiatric illness
- No hearing and perception problems,
- No loss of sensation in upper extremity according to light touch test,
- Any complications after surgery are undeveloped
Exclusion Criteria:
- Do not meet the inclusion criteria,
- Interrupting the research,
- Patients with incomplete answers to questions
Sites / Locations
- İnonu University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery
The Effect of Music Applied After Lumbar Disc Herniation Surgery
Pain, vital signs and NIRS values of patients after lumbar disc hernia surgery
Arm Description
Expressive touch reduces pain and keeps vital signs and NIRS values within normal limits by touching the arms and hands of the patients through energy transfer.
Patients listening to music are distracted and their pain is reduced, vital signs and NIRS values are kept within normal limits.
No intervention is applied to the patients in this group and the effectiveness of the interventions used on the patients in the other group is measured.
Outcomes
Primary Outcome Measures
Expressive touch applied to patients with lumbar disc herniation surgery reduces the level of pain.
the patient relaxes as a result of expressive touch, pain value will be measured by the verbal pain scale. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery doesn't reduce the level of pain.
the patient doesn't relaxes as a result of expressive touch, pain value will be measured by the verbal pain scale. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Music applied to patients with lumbar disc hernia surgery reduces the level of pain.
the patient relaxes as a result of music. the verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Music applied to patients with lumbar disc hernia surgery doesn't reduce the level of pain.
the patient doesn't relax as a result of music. the verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery is more effective than music in reducing pain.
the patient doesn't relax as a result of music but relaxes by expressive touch. The verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery is not more effective than music in reducing pain.
the patient doesn't relax as a result of expressive touch but relaxes by music. The verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery ensures that body temperature, pulse, respiratory rate, blood pressure, and saturation values are kept within physiological limits.
the patient relaxes as a result of expressive touch. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery doesn't affect body temperature, pulse, respiratory rate, blood pressure and saturation values within physiological limits.
the patient doesn't relax as a result of expressive touch. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Music applied to patients with lumbar disc herniation surgery ensures that body temperature, pulse, respiratory rate, blood pressure, and saturation values are kept within physiological limits.
the patient relaxes as a result of music. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Music applied to patients with lumbar disc herniation surgery doesn't affect body temperature, pulse, respiratory rate, blood pressure, and saturation values are kept within physiological limits.
the patient doesn't relax as a result of music. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery is more effective than music in keeping body temperature, pulse, respiratory rate, blood pressure, and saturation values are within physiological limits.
the patient doesn't relax as a result of music but relaxes by expressive touch. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery is not more effective than music in keeping body temperature, pulse, respiratory rate, blood pressure, and saturation values are within physiological limits.
the patient doesn't relax as a result of expressive touch but relaxes by music. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
The expressive touch applied to patients with lumbar disc herniation surgery increases the Near Infrared Spectroscopy (NIRS) value.
the patient relaxes as a result of expressive touch. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
The expressive touch applied to patients with lumbar disc herniation surgery doesn't increase the Near Infrared Spectroscopy (NIRS) value.
the patient doesn't relax as a result of expressive touch. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
The music applied to patients with lumbar disc herniation surgery increases the Near Infrared Spectroscopy (NIRS) value.
the patient relaxes as a result of music. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
The music applied to patients with lumbar disc herniation surgery doesn't increase the Near Infrared Spectroscopy (NIRS) value.
the patient doesn't relax as a result of music. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery is more effective than music in increasing NIRS values.
the patient doesn't relax as a result of music but relaxes by expressive touch. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Expressive touch applied to patients with lumbar disc herniation surgery is not more effective than music in increasing NIRS values.
the patient doesn't relax as a result of expressive touch but relaxes by music. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04765774
Brief Title
The Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery.
Acronym
NIRS
Official Title
The Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery on Pain, Vital Signs, and Near-infrared Spectroscopy (NIRS) Values.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients undergoing lumbar hernia surgery will be divided into expressive touch, music and control groups. Pre-test and post-test pain levels, vital signs, and NIRS values of the patients will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Nursing, Touch, Music, Pain, Near-İnfrared Spectroscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery
Arm Type
Experimental
Arm Description
Expressive touch reduces pain and keeps vital signs and NIRS values within normal limits by touching the arms and hands of the patients through energy transfer.
Arm Title
The Effect of Music Applied After Lumbar Disc Herniation Surgery
Arm Type
Experimental
Arm Description
Patients listening to music are distracted and their pain is reduced, vital signs and NIRS values are kept within normal limits.
Arm Title
Pain, vital signs and NIRS values of patients after lumbar disc hernia surgery
Arm Type
No Intervention
Arm Description
No intervention is applied to the patients in this group and the effectiveness of the interventions used on the patients in the other group is measured.
Intervention Type
Other
Intervention Name(s)
Ekspressive touch
Intervention Description
Patients will be divided into three groups. The expressive touch group will touch the patient's hand.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
The music chosen by the patient will be played in the music group.
Primary Outcome Measure Information:
Title
Expressive touch applied to patients with lumbar disc herniation surgery reduces the level of pain.
Description
the patient relaxes as a result of expressive touch, pain value will be measured by the verbal pain scale. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Expressive touch applied to patients with lumbar disc herniation surgery doesn't reduce the level of pain.
Description
the patient doesn't relaxes as a result of expressive touch, pain value will be measured by the verbal pain scale. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Music applied to patients with lumbar disc hernia surgery reduces the level of pain.
Description
the patient relaxes as a result of music. the verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Music applied to patients with lumbar disc hernia surgery doesn't reduce the level of pain.
Description
the patient doesn't relax as a result of music. the verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Expressive touch applied to patients with lumbar disc herniation surgery is more effective than music in reducing pain.
Description
the patient doesn't relax as a result of music but relaxes by expressive touch. The verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Expressive touch applied to patients with lumbar disc herniation surgery is not more effective than music in reducing pain.
Description
the patient doesn't relax as a result of expressive touch but relaxes by music. The verbal pain scale will be measured pain value. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Expressive touch applied to patients with lumbar disc herniation surgery ensures that body temperature, pulse, respiratory rate, blood pressure, and saturation values are kept within physiological limits.
Description
the patient relaxes as a result of expressive touch. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
1 and a half hours
Title
Expressive touch applied to patients with lumbar disc herniation surgery doesn't affect body temperature, pulse, respiratory rate, blood pressure and saturation values within physiological limits.
Description
the patient doesn't relax as a result of expressive touch. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
1 and a half hours
Title
Music applied to patients with lumbar disc herniation surgery ensures that body temperature, pulse, respiratory rate, blood pressure, and saturation values are kept within physiological limits.
Description
the patient relaxes as a result of music. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
1 and a half hours
Title
Music applied to patients with lumbar disc herniation surgery doesn't affect body temperature, pulse, respiratory rate, blood pressure, and saturation values are kept within physiological limits.
Description
the patient doesn't relax as a result of music. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
1 and a half hours
Title
Expressive touch applied to patients with lumbar disc herniation surgery is more effective than music in keeping body temperature, pulse, respiratory rate, blood pressure, and saturation values are within physiological limits.
Description
the patient doesn't relax as a result of music but relaxes by expressive touch. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
1 and a half hours
Title
Expressive touch applied to patients with lumbar disc herniation surgery is not more effective than music in keeping body temperature, pulse, respiratory rate, blood pressure, and saturation values are within physiological limits.
Description
the patient doesn't relax as a result of expressive touch but relaxes by music. Body temperature will be measured with a digital thermometer. Pulse and blood pressure value will be measured with a digital sphygmomanometer. The respiratory rate will be calculated by counting. Oxygen saturation will be measured by pulse oximetry. The initiative will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
1 and a half hours
Title
The expressive touch applied to patients with lumbar disc herniation surgery increases the Near Infrared Spectroscopy (NIRS) value.
Description
the patient relaxes as a result of expressive touch. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
The expressive touch applied to patients with lumbar disc herniation surgery doesn't increase the Near Infrared Spectroscopy (NIRS) value.
Description
the patient doesn't relax as a result of expressive touch. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
The music applied to patients with lumbar disc herniation surgery increases the Near Infrared Spectroscopy (NIRS) value.
Description
the patient relaxes as a result of music. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
The music applied to patients with lumbar disc herniation surgery doesn't increase the Near Infrared Spectroscopy (NIRS) value.
Description
the patient doesn't relax as a result of music. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Expressive touch applied to patients with lumbar disc herniation surgery is more effective than music in increasing NIRS values.
Description
the patient doesn't relax as a result of music but relaxes by expressive touch. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
Title
Expressive touch applied to patients with lumbar disc herniation surgery is not more effective than music in increasing NIRS values.
Description
the patient doesn't relax as a result of expressive touch but relaxes by music. NIRS value will be measured by a digital measuring device. The attempt will be evaluated 3 times. 44 patients will be measured in the touch group.
Time Frame
30 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Agreeing to participate in the research,
General anesthesia applied,
Patients with the same type of treatment protocol,
Verbal pain score with at least 4,
Patients with a Ramsay sedation Scale score of 3 and below,
Without a chronic disease,
Without a disease (AVM, blockage of brain vessels, etc.) that will affect brain oxygenation,
Who has not been diagnosed with any psychiatric illness
No hearing and perception problems,
No loss of sensation in upper extremity according to light touch test,
Any complications after surgery are undeveloped
Exclusion Criteria:
Do not meet the inclusion criteria,
Interrupting the research,
Patients with incomplete answers to questions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
meral özkan, PhD
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İnonu University
City
Battalgazi
State/Province
Malatya
ZIP/Postal Code
44200
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery.
We'll reach out to this number within 24 hrs