Lumbar Disc HerniationNIRSNCT04765774
The Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery.
A study testing Ekspressive touch and Music in people with Lumbar Disc Herniation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Ekspressive touch and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2021to 30 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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
Who cannot join
- Do not meet the inclusion criteria,
- Interrupting the research,
- Patients with incomplete answers to questions
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Ekspressive touch, Music
- Keywords
- Nursing, Touch, Music, Pain, Near-İnfrared Spectroscopy
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ekspressive touchOther
Patients will be divided into three groups. The expressive touch group will touch the patient's hand.
MusicOther
The music chosen by the patient will be played in the music group.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery | Experimental | 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. Receives: Other: Ekspressive touch |
| The Effect of Music Applied After Lumbar Disc Herniation Surgery | Experimental | Patients listening to music are distracted and their pain is reduced, vital signs and NIRS values are kept within normal limits. Receives: Other: Music |
| Pain, vital signs and NIRS values of patients after lumbar disc hernia surgery | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 1 and a half hours
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.
Measured: 1 and a half hours
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.
Measured: 1 and a half hours
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.
Measured: 1 and a half hours
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.
Measured: 1 and a half hours
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.
Measured: 1 and a half hours
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
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.
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start22 Feb 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan SÖYLEMEZ, Inonu University
- Investigators
- meral özkan, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765774
- Sponsor's protocol ID
- InonuUniversity
- Acronym
- NIRS
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04765774
- Acronym / sponsor ID
- NIRS / InonuUniversity
- Conditions
- Lumbar Disc Herniation
- Keywords
- Nursing, Touch, Music, Pain, Near-İnfrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 21 Feb 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery | Experimental | Other: Ekspressive touchExpressive 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. |
| The Effect of Music Applied After Lumbar Disc Herniation Surgery | Experimental | Other: MusicPatients listening to music are distracted and their pain is reduced, vital signs and NIRS values are kept within normal limits. |
| Pain, vital signs and NIRS values of patients after lumbar disc hernia surgery | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (3 listed)
- Do not meet the inclusion criteria,
- Interrupting the research,
- Patients with incomplete answers to questions
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 |
|---|---|---|
| Ekspressive touchPatients will be divided into three groups. The expressive touch group will touch the patient's hand. | Other | The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery |
| MusicThe music chosen by the patient will be played in the music group. | Other | The Effect of Music Applied After Lumbar Disc Herniation Surgery |
Primary outcome
Expressive touch applied to patients with lumbar disc herniation surgery reduces the level of pain.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 1 and a half hours
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.
Time frame: 1 and a half hours
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.
Time frame: 1 and a half hours
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.
Time frame: 1 and a half hours
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.
Time frame: 1 and a half hours
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.
Time frame: 1 and a half hours
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Time frame: 30 minute
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Related trials for Lumbar Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
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.
meral özkan, PhD principal investigator
Inonu 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 Ekspressive touch and Music in people with Lumbar Disc Herniation, run by Inonu 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 11 inclusion and 3 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: finished, as of the sponsor's last update on 13 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expressive touch applied to patients with lumbar disc herniation surgery reduces the level of pain. (time frame: 30 minute). The study lists 18 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 13 Feb 2024.