The Effect of Expressive Touch and Music Applied After Lumbar Disc Hernia Surgery. (NIRS)

February 10, 2024 updated by: Neslihan SÖYLEMEZ, Inonu University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Malatya
      • Battalgazi, Malatya, Turkey, 44200
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery
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.
Other: Ekspressive touch
Patients will be divided into three groups. The expressive touch group will touch the patient's hand.
Experimental: The Effect of Music Applied After Lumbar Disc Herniation Surgery
Patients listening to music are distracted and their pain is reduced, vital signs and NIRS values are kept within normal limits.
Other: Music
The music chosen by the patient will be played in the music group.
No Intervention: Pain, vital signs and NIRS values of patients after lumbar disc hernia surgery
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minute
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.
30 minute
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.
30 minute
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.
30 minute
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.
30 minute
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 and a half hours
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.
30 minute
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.
30 minute
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.
30 minute
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.
30 minute
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.
30 minute
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.
30 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: meral özkan, PhD, Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InonuUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Disc Herniation

Clinical Trials on Ekspressive touch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe