Pain, Anxiety of Aromatherapy and Music Effect on

NCT ID: NCT06024954

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-07-15

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

music therapy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

aromatherapy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

aromatherapy and music therapy

Intervention Type: 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.

control group

Participants were not interfered with.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

aromatherapy inhaler.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Duygu Akbas Uysal

Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DUYGU AKBAŞ UYSAL

Role: PRINCIPAL_INVESTIGATOR

PHD.candidate

Locations

EGE

Izmir, İ̇zmi̇r, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 39230757 (View on PubMed)

Other Identifiers

DUYGU AKBAŞ UYSAL

Identifier Type: OTHER

Identifier Source: secondary_id

EGE UNIVERSTY

Identifier Type: -

Identifier Source: org_study_id