Pain, Anxiety of Aromatherapy and Music Effect on

NCT06024954 | Completed

• 2 other identifiers: EGE UNIVERSTYDUYGU AKBAŞ UYSAL
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

pallative care; aromatherapy; music therapy

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale (VAS)

  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)

  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

  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)

  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

  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

Study Arms (4)

music group

EXPERIMENTAL

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

aromatherapy group

EXPERIMENTAL

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

aromatherapy and music group

EXPERIMENTAL

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

control group

NO INTERVENTION

Participants were not interfered with.

Interventions

aromatherapy OTHER

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.

Also known as: aromatherapy inhaler.

aromatherapy group

music therapy OTHER

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.

music group

aromatherapy and music therapy OTHER

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.

aromatherapy and music group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

EGE

Izmir, İ̇zmi̇r, 3590, Turkey (Türkiye)

Location

Related Publications (1)

• Akbas Uysal D, Senuzun Aykar F, Uyar M. The effects of aromatherapy and music on pain, anxiety, and stress levels in palliative care patients. Support Care Cancer. 2024 Sep 4;32(10):632. doi: 10.1007/s00520-024-08837-0.

  PMID: 39230757 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Aromatherapy; Music Therapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• DUYGU AKBAŞ UYSAL

  PHD.candidate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: September 6, 2023
• Study Start: August 10, 2022
• Primary Completion: September 10, 2022
• Study Completion: July 15, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)