Pain, Anxiety of Aromatherapy and Music Effect on

Cancer Clinical Trial

— Palliative  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06024954
• Other study ID #: EGE UNIVERSTY
• Secondary ID: DUYGU AKBAS UYSA
• Status: Completed
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: August 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 15, 2023
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	EGE	Izmir	I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

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