Pain, Anxiety of Aromatherapy and Music Effect on (Palliative)

August 29, 2023 updated by: Duygu Akbas Uysal, Ege University

Palliative Care Pain, Anxiety and Vital Inhaler Effect of Aromatherapy Applied to Patients and Music Effect on Parameters

The research is planned as a randomized controlled trial. The main question[s] it aims to answer are:

[question 1]: Does the inhaler effect of music and aromatherapy applied to palliative care patients have an effect on pain, anxiety and vital signs?

The individuals in the research group are divided into four groups as music group, aromatherapy group, music and aromatherapy and control group. .

Before and at the end of the intervention, data collection tools [Patient Description Form, Visual analog scale,face anxiety scale, Distress Thermometer, Edmonton Symptom Scale] will record the characteristics of pain, anxiety and vital parameters.

Patient Identification Form: It is a questionnaire that includes sociodemographic characteristics (gender, age, educational status, income status, employment status and occupation) and questions about the disease, created by the researchers by scanning the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The relaxing music group listened to specially composed "MusiCure®" compositions in soft rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain, bird, forest sound).The patients in the experimental group listened to music with headphones for 20 minutes for three consecutive days.Pain, anxiety and vital parameters were recorded with data collection tools [Patient Description Form, VAS, FAS, Distress Thermometer, Edmonton Symptom Scale] before and at the end of the intervention.For the patients in the aromatherapy group, use 5% lavender oil with a diffuser for 15-20 minutes.

has been applied.The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.The patients hospitalized in the palliative care service were given music with a loudspeaker for three consecutive days with the effect of aromatherapy inhaler.

Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.

Study Type

Interventional

Enrollment (Actual)

88

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
    • İ̇zmi̇r
      • İzmir, İ̇zmi̇r, Turkey, 3590
        • EGE

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • who volunteered to participate in the research,
  • 18 years and older,
  • No hearing problem
  • Doesn't have any problems with smelling healthy,
  • No communication and speech problems

Exclusion Criteria:

  • with a diagnosis of psychiatric illness,
  • Allergic to lavender, perfumes or cosmetics,
  • Having asthma and chronic obstructive pulmonary disease

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: music group

The research is planned as a randomized controlled trial. The individuals in the research group are divided into four groups as music group, aromatherapy group, music and aromatherapy and control group. The relaxing music group will listen to specially composed "MusiCure®" compositions in soft rhythm, including melodies with harp, cello, strings and natural sound elements (eg rain, bird, forest sound). The patients in the experimental group will listen to the music with headphones for 20 minutes for three consecutive days.

Before and at the end of the intervention, data collection tools [Patient Description Form, Vısual analog scale, facial anxiety scale , Distress Thermometer, Edmonton Symptom Scale] will record the characteristics of pain, anxiety and vital parameters.
Other: music therapy
The relaxing music group listened to specially composed "MusiCure®" compositions in soft rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain, bird, forest sound). Listened with headphones for 20 minutes.
Experimental: aromatherapy group

Patients in the aromatherapy group use 5% lavender oil with a diffuser for 15-20 minutes in accordance with the "Aromatherapy-Clinical Guideline For Midwives. NHS".

Trust 1-15) has been applied. The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again, and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.
Other: aromatherapy

Patients in the aromatherapy group use 5% lavender oil with a diffuser for 15-20 minutes in accordance with the "Aromatherapy-Clinical Guideline For Midwives. NHS".

Trust 1-15) has been applied. The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again, and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.

Other Names:
  • aromatherapy inhaler.
Experimental: aromatherapy and music group
Inpatients in the palliative care service will be given music with headphones for three consecutive days with the effect of aromatherapy inhaler. Within 10-15 minutes after the completion of the inhalation, data collection forms will be applied again and pain, anxiety, blood pressure, pulse and respiratory rate will be evaluated.
Other: aromatherapy and music therapy
Inpatients will be given music with a loudspeaker with the effect of aromatherapy inhaler for three consecutive days. Within 10-15 minutes after the completion of the inhalation, data collection forms will be applied again, pain, anxiety, blood pressure, pulse, respiratory rate were evaluated.
No Intervention: control group
Participants were not interfered with.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: three consecutive days after the start of application
The Visual Analog Scale (VAS) used for the assessment of pain is used to digitize some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at both ends of a 10 cm or 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.
three consecutive days after the start of application
Facial Anxiety Scale (FAS)
Time Frame: three consecutive days after the start of application
The Facial Anxiety Scale is a measurement tool in which patients report their anxiety levels. The scale consists of five face shapes with the size of 11 × 42 cm. While the facial expression on the far left indicates the absence of anxiety, the level of anxiety increases towards the right (scored between 0-5). A score of three or more on the Facial Anxiety Scale indicates that the anxiety level is moderate or high.
three consecutive days after the start of application
Distress Thermometer
Time Frame: three consecutive days after the start of application
Distress Thermometer The Thermometer with Distress Thermometer is a likert-type scale with scores from 0 (no stress) to 10 (extreme stress).the class of the values in the degree is indicated as points
three consecutive days after the start of application
Edmonton Symptom Diagnostic Scale((ESAS)
Time Frame: three consecutive days after the start of application
The patient is asked to match his symptoms with a number that he thinks is most suitable for him from the numbers from 0 to 10. The number 0 indicates no symptoms, the number 10 indicates that the symptom is very severe.All of the items on the ESAS have a value of 0-10 points
three consecutive days after the start of application
vital parameters
Time Frame: three consecutive days after the start of application
blood pressure measurement, pulse, respiratory rate will be measured.120-129/80-84 mmHg is normal, 130-139/85-89 mmHg( millimeters of mercury (mmHg) ) is called high normal blood pressure.Respirations per minute in a healthy adult person 12-20.(12-20 breaths per minute)It is normal for adults and healthy people to have a heart rate in the range of 60-100 beats per minute.Heart rate (or pulse rate)(heart per minute (beats per minute, or bpm)(60 to 100 bpm);
three consecutive days after the start of application

Collaborators and Investigators

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

Sponsor

Ege University

Investigators

  • Principal Investigator: DUYGU AKBAŞ UYSAL, PHD.candidate

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)

August 10, 2022

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Estimated)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EGE UNIVERSTY
  • DUYGU AKBAŞ UYSAL (Other Identifier: EGE UNIVERSTY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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