NCT04765774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 4, 2021

Last Update Submit

February 10, 2024

Conditions

Lumbar Disc Herniation

Keywords

NursingTouchMusicPainNear-İnfrared Spectroscopy

Outcome Measures

Primary Outcomes (18)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    30 minute

Study Arms (3)

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.

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.

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.

Interventions

Ekspressive touchOTHER

Patients will be divided into three groups. The expressive touch group will touch the patient's hand.

The Effect of Expressive Touch Applied After Lumbar Disc Herniation Surgery
MusicOTHER

The music chosen by the patient will be played in the music group.

The Effect of Music Applied After Lumbar Disc Herniation Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Interrupting the research,
  • Patients with incomplete answers to questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnonu University

Battalgazi, Malatya, 44200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementPain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • meral özkan, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 21, 2021

Study Start

February 22, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

TU(1)