Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:05 AM
Study NCT ID:
NCT05481294
Status:
UNKNOWN
Last Update Posted:
2022-12-28
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supportive Coaching Intervention in PLWHA
Sponsor:
Muh. Yusuf Tahir
Organization:
Study Overview
Official Title:
The Effectivity of Transpersonal Supportive Coaching Intervention on Serotonin Level and Quality of Life in People Living With HIV/AIDS (PLWHA)
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
RECRUITING
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:
Introduction:
Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support.
Objective:
To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA.
Method:
This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses.
Alternative hypothesis:
1. There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA.
2. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA
Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support.
Objective:
To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA.
Method:
This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses.
Alternative hypothesis:
1. There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA.
2. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA
Detailed Description:
Sampling technique: Purposive sampling
Sample Size :
The estimation of sample size was calculated using the Slovin formula:
n = N / (1 + (N x e²))
n = sample N = population e = margin error (0.05)
n = 100/(1+100 x 0.0025) = 80
The sample will be divided into 3 groups (each group = 26.67 or 27).
Detailed Intervention:
1. Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy.
2. Control group I: A group was given only basic support for 4 months and taking ARV therapy.
3. Control group II: A group only taking ARV therapy without any support was given.
Statistical analysis:
1. Qualitative analysis using thematic and content analysis with N-Vivo software
2. Quantitative analysis:
1. Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval
2. Bivariate analysis using Anova or Kruskal Wallis tests.
3. Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method
4. Data will analysis using SPSS version 26
Sample Size :
The estimation of sample size was calculated using the Slovin formula:
n = N / (1 + (N x e²))
n = sample N = population e = margin error (0.05)
n = 100/(1+100 x 0.0025) = 80
The sample will be divided into 3 groups (each group = 26.67 or 27).
Detailed Intervention:
1. Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy.
2. Control group I: A group was given only basic support for 4 months and taking ARV therapy.
3. Control group II: A group only taking ARV therapy without any support was given.
Statistical analysis:
1. Qualitative analysis using thematic and content analysis with N-Vivo software
2. Quantitative analysis:
1. Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval
2. Bivariate analysis using Anova or Kruskal Wallis tests.
3. Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method
4. Data will analysis using SPSS version 26
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?: