UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032594 |
|---|---|
| Receipt number | R000037153 |
| Scientific Title | The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2022/11/16 09:46:30 |
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Basic information
Public title
The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students
Acronym
Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being
Scientific Title
The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students
Scientific Title:Acronym
Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being
Region
| Asia(except Japan) |
Condition
Condition
Healthy individual
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To study the effects of nature connectedness and spiritual practice of Dhikr in influencing the psychological and physiological well-being of Malaysian Muslim students.
Basic objectives2
Others
Basic objectives -Others
1. To examine the levels and patterns of psychological well-being (intensity of emotional stress responses), ecopsychological and spiritual values, as well as physiological measures of stress (blood pressure, salivary cortisol and alpha-amylase) among Malaysia Muslim students.
2. To study the effects of indoor and outdoor green exposure on the levels of psychological well-being, ecopsychological and spiritual values, as well as physiological measures of stress among Malaysia Muslim students.
3. To study the effects of spiritual practice of Dhikr in both indoor and outdoor environments on the levels of psychological well-being, ecopsychological and spiritual values, as well as physiological measures of stress among Malaysia Muslim students.
4. To realise the manipulation of body functions through differential gene expression patterns following indoor and outdoor green exposure, with or without the spiritual practice of Dhikr.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in the levels of psychological well-being, ecopsychological and spiritual values pre- and post-experimental exposure
Key secondary outcomes
The difference in blood pressure, salivary cortisol levels, salivary alpha amylase levels and blood gene expression pattern pre- and post-experimental exposure
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Indoor exposure without spiritual practice of Dhikr
Interventions/Control_2
Indoor exposure with spiritual practice of Dhikr
Interventions/Control_3
Outdoor exposure without spiritual practice of Dhikr
Interventions/Control_4
Outdoor exposure with spiritual practice of Dhikr
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Malaysia Matriculation students;
Muslim,
BMI: 18.5-24.9;
Not taking any medication (including herbal medicine and supplement).
Key exclusion criteria
Malignancy, immunodeficiency, autoimmune disorders, hepatitis, hypertension, HIV infection, or smoking.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Samsilah |
| Middle name | |
| Last name | Roslan |
Organization
Universiti Putra Malaysia
Division name
Faculty of Educational Studies
Zip code
43300
Address
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
TEL
60389471413
samsilah@upm.edu.my
Public contact
Name of contact person
| 1st name | Samsilah |
| Middle name | |
| Last name | Roslan |
Organization
Universiti Putra Malaysia
Division name
Faculty of Educational Studies
Zip code
43300
Address
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
TEL
60389471413
Homepage URL
http://www.educ.upm.edu.my/
samsilah@upm.edu.my
Sponsor or person
Institute
Faculty of Educational Studies, Universiti Putra Malaysia
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education Malaysia
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
Address
The Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia, Research Management Centre, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
Tel
60389471244
dir.rmc@upm.edu.my
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037153
Publication of results
Unpublished
Result
URL related to results and publications
http://dx.doi.org/10.6007/IJARBSS/v12-i9/14784
Number of participants that the trial has enrolled
149
Results
The present findings support the stress-relieving effects following co-exposure to nature and dhikr meditation via improvements in both psychological and physiological well-being.
Results date posted
| 2019 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 19 | Day |
Baseline Characteristics
Characteristic Outdoor Indoor
Dhikr Non-dhikr Dhikr Non-dhikr
Total participants (No.) 35 38 39 37
Gender
Male (No.) 17 17 26 19
Female (No.) 18 21 13 18
Body Mass Index (No.)
<18.5 kg m-2 4 3 4 4
18.5 to 24.9 kg m-2 29 33 35 29
> 25 kg m-2 2 2 3 4
Age (Years) 18-23
Religion
Islam (%) 100
Currently pregnant No
Smoking No
Currently taking medication No
Major health problem No
Participant flow
Outdoor Indoor
Dhikr Non-dhikr Dhikr Non-dhikr
Started 35 38 39 37
Gender
Male (No.) 17 17 26 19
Female (No.) 18 21 13 18
Completed 35 38 39 37
Non-completed 0 0 0 0
Analysis 35 38 39 37
Adverse events
Not available
Outcome measures
Effects of exposure to nature greens and dhikr on profile of mood states
Profile of mood states (POMS) scores at pre- and post-exposure for all the different experimental settings are presented in Table 2. In brief, there were no significant differences at pre-experimental exposure, indicating that all the groups were initially equalled on mood disturbances by the randomization procedure. At post-experimental exposure, significant differences (p < 0.05) were observed for POMS scores on the subscales of tension, fatigue, confusion, vigor, calmness and total mood disturbances. Exposure to outdoor greenery environment positively influenced the mood of study participants in comparison to those exposed to the indoor environment. Similarly, the meditative-practice of dhikr, under both outdoor and indoor conditions, significantly improved POMS scores at post-exposure. Further analysis on the change scores, however, indicated that combination exposure to both nature and dhikr triggered greater decrease in mood disturbance on the subscales of tension, depression, anger, fatigue, confusion and total mood disturbances. In particular, the outdoor dhikr group recorded 44.44, 57.78 and 60.00% (p < 0.05) reduction in total mood disturbances when compared to the outdoor non-dhikr, indoor dhikr and indoor non-dhikr groups respectively.
Effects of exposure to nature and dhikr on ecopsychology and spiritual values
Exposure to nature and meditative-practice of dhikr differentially affected ecopsychology and spiritual values of the study participants. The data are shown in Table 3. At pre-experimental exposure, all the groups shared similar scores and were matched for both ecopsychology and spiritual values. Surprisingly, at post-experimental exposure, dhikr meditation in both outdoor and indoor environments significantly affected the ecopsychological values that seek to understand the emotional connection between an individual and the nature, but not spiritual values that confer reverence toward the universe. The outdoor dhikr and indoor dhikr groups respectively experienced 13.74 and 15.27% (p < 0.05) higher ecopsychological values in comparison to the indoor non-dhikr group. Further analysis on the change scores, however, demonstrated that the participants who were exposed to nature and dhikr meditation concurrently had a more positive impact on both ecopsychology and spirituality. The outdoor dhikr group recorded approximately 25.80- and 7.41-fold increase (p < 0.05) in ecopsychology and spiritual values respectively when compared to the indoor non-dhikr group. On the other hand, meditative practice of dhikr in an indoor environment demonstrated significant improvement in spirituality, approximately 34.46-fold increase (p < 0.05) in comparison to indoor non-dhikr group, but not in ecopsychology, essentially indicating effect of dhikr meditation even if modulatory on the nature exposure.
Pulse rate and blood pressure
Pulse rate and blood pressure measurements are shown in Table 4. Briefly, pulse rate remain stable throughout the whole experimental exposure across all the different environmental settings. The different exposures appeared not to have any significant effects on the parameter. In addition, there was also no significant difference in the systolic and diastolic blood pressure measurements at pre-experimental exposure. Nevertheless, significant changes in systolic blood pressure measurements were observed after the experimental procedure. In comparison to the other groups at post-experimental exposure, the outdoor non-dhikr recorded the lowest (p < 0.05) systolic blood pressure.
Saliva cortisol and alpha amylase
The salivary stress markers levels are depicted in Figure 2. In accordance with the psychological measurements findings, there were no significant differences in the salivary cortisol and alpha amylase levels at the beginning of the study. Significant reductions in the salivary cortisol levels were observed post-experimental exposure. The outdoor dhikr, outdoor non-dhikr and indoor dhikr groups respectively recorded 34.75, 43.94 and 31.86% (p < 0.05) reduction in salivary cortisol levels when compared to the indoor non-dhikr group. Collectively, the results suggest an all-or-none effect on saliva cortisol level when exposed to nature and dhikr at the same time. Change scores revealed that both outdoor groups experienced greater reduction in the salivary cortisol levels in comparison to the indoor groups. Significant reductions ranging between 4.51- to 7.14-fold (p < 0.05) were observed.
On the other hand, the salivary alpha amylase levels increased slightly for both indoor groups at post-experimental exposure. In comparison to the outdoor dhikr and outdoor non-dhikr groups, the indoor dhikr group recorded 2.08- and 1.92-fold (p < 0.05) increase while the indoor non-dhikr groups recorded 1.38- and 1.28-fold (p < 0.05) increase respectively in the enzyme levels. The meditative-practice of dhikr did not affect the salivary alpha amylase stress response under both outdoor and indoor settings. In addition, the change scores were also not significantly different among the four different experimental groups.
Plan to share IPD
No
IPD sharing Plan description
There is not a plan to make IPD available.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037153
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