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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04765774
Other study ID # InonuUniversity
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date July 30, 2021

Study information

Verified date February 2024
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Ekspressive touch
Patients will be divided into three groups. The expressive touch group will touch the patient's hand.
Music
The music chosen by the patient will be played in the music group.

Locations

Country Name City State
Turkey Inonu University Battalgazi Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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