Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-02 @ 7:02 AM
Study NCT ID:
NCT04957966
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2021-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ecological Momentary Music Intervention for the Reduction of Stress
Sponsor:
University of Vienna
Organization:
Study Overview
Official Title:
An Ecological Momentary Music Intervention for the Reduction of Stress in the Daily Life of Turkish Immigrant Women
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ethnic discrimination is a prevalent problem in the European Union and other regions. In view of the significant negative impacts of discrimination on mental and physical health, it is of high relevance to counteract these negative effects and provide appropriate interventions. This study aims to investigate the feasibility and the effectiveness of a mobile-based intervention, delivering self-selected relaxing music to buffer biological (salivary cortisol, salivary alpha-amylase) and psychological (perceived stress, perceived ethnic discrimination) stress reactions in moments of acute stress and perceived ethnic discrimination in the everyday life of Turkish immigrant women (N=20, age range 18-65 years). An intra-individually randomized design will be used, i.e., participants will be instructed on a random basis to either listen to music (intervention event) or not (control event). The whole study period consists of 35 days with a baseline period (week 1), intervention period (week 2-4), and post period (week 5). To investigate the feasibility of the intervention, post-monitoring interviews will be conducted after the end of the whole study period.
Detailed Description:
The experience of unfair treatment because of one's own ethnicity, i.e., ethnic discrimination, constitutes a complex stressor which triggers both physical and psychological stress reactions. In this regard, women may constitute a particularly vulnerable group, as they may be confronted with intersectional stigmata, i.e., both ethnicity-related and gender-related stigmata. Considering the resulting health impairments many people with migration background are confronted with, it is of great importance to provide interventions with the potential to minimize those negative consequences. Recognizing this necessity, an ecological momentary music intervention was developed in order to reduce psychological and biological (cortisol, alpha-amylase) stress levels due to perceived ethnic discrimination in everyday life. The primary aim of this study is to investigate the feasibility and the effectiveness of this mobile-based intervention.
It is hypothesized that listening to music after an event of acute stress and/or ethnic discrimination will result in stronger decreases in psychological (perceived stress, perceived ethnic discrimination), and biological (cortisol, alpha-amylase) stress levels compared to no music listening in everyday life (immediate effect). Further, it is expected that a decrease in diurnal psychological and biological stress levels will be observed throughout the study period (intermediate effect) and that participants will start to consume or increase their deliberate consumption of music after an event of acute stress and/or ethnic discrimination in their everyday life after the intervention (behavior change). In addition, it is hypothesized that the feasibility of the intervention will be confirmed by participants' self-reports of high usefulness of and satisfaction with the intervention as well as by a high usage rate.
The study design is as follows: Baseline period (week 1), intervention period (week 2 to 4), post period (week 5).
During the baseline and post period, psychological and biological stress fluctuations and perceived ethnic discrimination in daily life will be assessed. To this end, participants will be signaled three times a day (9:00 am, 2:00 pm, 7:00 pm) in order to answer questions on their momentary levels of stress, perceived discrimination, positive and negative affect, and their music-listening activities (time-contingent data entries). Additionally, whenever a stressful or discriminatory event occurs, participants are instructed to initiate a data entry by themselves in order to report their momentary levels of stress, perceived discrimination, positive and negative affect, and to answer questions on the current situation. To investigate activities after such self-initiated, event-contingent data entries, the app will signal the participants 20 (post 1) and 35 minutes (post 2) later for an additional data entry. As part of every time-contingent and event-contingent report, participants will provide a saliva sample in order to examine biological stress markers: salivary cortisol levels as index of hypothalamic-pituitary-adrenal axis (HPA axis) activity, salivary alpha-amylase as index of autonomic nervous system (ANS) activity.
A daily diary assessment will be conducted every evening at the same time. In this diary, participants will be asked about their current perceived stress, perceived discrimination, positive and negative affect, fatigue, coping strategies. Additionally, they will be asked whether discriminatory events had happened over the course of the day and if so, to describe the event(s). For this data entry, no saliva sample will be collected.
During the Intervention period (week 2 to 4), the sampling protocol will be the same as in baseline and post period (i.e., time-contingent data entries, daily diary assessment, self-initiated event-contingent data entries, post 1, post 2). Additionally, after every self-initiated event-contingent report, participants will be randomly assigned (50:50) to either the intervention event (listening to music for 20 minutes) or the control event (no music listening, continue the activity before the data entry). This approach constitutes an intra-individually randomized design.
To investigate the feasibility of the intervention, qualitative data from post-monitoring interviews will be gathered at the end of the study period.
It is hypothesized that listening to music after an event of acute stress and/or ethnic discrimination will result in stronger decreases in psychological (perceived stress, perceived ethnic discrimination), and biological (cortisol, alpha-amylase) stress levels compared to no music listening in everyday life (immediate effect). Further, it is expected that a decrease in diurnal psychological and biological stress levels will be observed throughout the study period (intermediate effect) and that participants will start to consume or increase their deliberate consumption of music after an event of acute stress and/or ethnic discrimination in their everyday life after the intervention (behavior change). In addition, it is hypothesized that the feasibility of the intervention will be confirmed by participants' self-reports of high usefulness of and satisfaction with the intervention as well as by a high usage rate.
The study design is as follows: Baseline period (week 1), intervention period (week 2 to 4), post period (week 5).
During the baseline and post period, psychological and biological stress fluctuations and perceived ethnic discrimination in daily life will be assessed. To this end, participants will be signaled three times a day (9:00 am, 2:00 pm, 7:00 pm) in order to answer questions on their momentary levels of stress, perceived discrimination, positive and negative affect, and their music-listening activities (time-contingent data entries). Additionally, whenever a stressful or discriminatory event occurs, participants are instructed to initiate a data entry by themselves in order to report their momentary levels of stress, perceived discrimination, positive and negative affect, and to answer questions on the current situation. To investigate activities after such self-initiated, event-contingent data entries, the app will signal the participants 20 (post 1) and 35 minutes (post 2) later for an additional data entry. As part of every time-contingent and event-contingent report, participants will provide a saliva sample in order to examine biological stress markers: salivary cortisol levels as index of hypothalamic-pituitary-adrenal axis (HPA axis) activity, salivary alpha-amylase as index of autonomic nervous system (ANS) activity.
A daily diary assessment will be conducted every evening at the same time. In this diary, participants will be asked about their current perceived stress, perceived discrimination, positive and negative affect, fatigue, coping strategies. Additionally, they will be asked whether discriminatory events had happened over the course of the day and if so, to describe the event(s). For this data entry, no saliva sample will be collected.
During the Intervention period (week 2 to 4), the sampling protocol will be the same as in baseline and post period (i.e., time-contingent data entries, daily diary assessment, self-initiated event-contingent data entries, post 1, post 2). Additionally, after every self-initiated event-contingent report, participants will be randomly assigned (50:50) to either the intervention event (listening to music for 20 minutes) or the control event (no music listening, continue the activity before the data entry). This approach constitutes an intra-individually randomized design.
To investigate the feasibility of the intervention, qualitative data from post-monitoring interviews will be gathered at the end of the study period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: