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UMIN ID:

試験進捗状況 参加者募集終了‐試験継続中/No longer recruiting
UMIN試験ID UMIN000032594
受付番号 R000037153
科学的試験名
一般公開日(本登録希望日) 2018/05/14
最終更新日 2019/06/25

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title
The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students
一般向け試験名略称/Acronym
Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being
科学的試験名/Scientific Title
The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students
科学的試験名略称/Scientific Title:Acronym
Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Healthy individual
疾患区分1/Classification by specialty
該当せず/Not applicable 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information はい/YES

目的/Objectives
目的1/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.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/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.
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
The difference in the levels of psychological well-being, ecopsychological and spiritual values pre- and post-experimental exposure
副次アウトカム評価項目/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

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 要因デザイン/Factorial
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 4
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
Indoor exposure without spiritual practice of Dhikr
介入2/Interventions/Control_2
Indoor exposure with spiritual practice of Dhikr
介入3/Interventions/Control_3
Outdoor exposure without spiritual practice of Dhikr
介入4/Interventions/Control_4
Outdoor exposure with spiritual practice of Dhikr
介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
23 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Malaysia Matriculation students;
Muslim,
BMI: 18.5-24.9;
Not taking any medication (including herbal medicine and supplement).
除外基準/Key exclusion criteria
Malignancy, immunodeficiency, autoimmune disorders, hepatitis, hypertension, HIV infection, or smoking.

目標参加者数/Target sample size 160

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Samsilah
ミドルネーム
Roslan
所属組織/Organization
Universiti Putra Malaysia
所属部署/Division name
Faculty of Educational Studies
郵便番号/Zip code 43300
住所/Address
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
電話/TEL 60389471413
Email/Email samsilah@upm.edu.my

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Samsilah
ミドルネーム
Roslan
組織名/Organization
Universiti Putra Malaysia
部署名/Division name
Faculty of Educational Studies
郵便番号/Zip code 43300
住所/Address
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
電話/TEL 60389471413
試験のホームページURL/Homepage URL http://www.educ.upm.edu.my/
Email/Email samsilah@upm.edu.my

実施責任組織/Sponsor
機関名/Institute その他 Faculty of Educational Studies, Universiti Putra Malaysia
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Ministry of Education Malaysia
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他の国の官庁/Government offices of other countries
研究費拠出国/Nationality of Funding Organization
Malaysia

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
The Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
住所/Address
The Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia, Research Management Centre, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
電話/Tel 60389471244
Email/Email dir.rmc@upm.edu.my

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 05 14

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037153
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications Not available
組み入れ参加者数/Number of participants that the trial has enrolled 149
主な結果/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. 
主な結果入力日/Results date posted
2019 06 25
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/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
参加者の流れ/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
有害事象/Adverse events
Not available
評価項目/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.
個別症例データ共有計画/Plan to share IPD
No
個別症例データ共有計画の詳細/IPD sharing Plan description
There is not a plan to make IPD available.

試験進捗状況/Progress
試験進捗状況/Recruitment status 参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation
2017 07 19
倫理委員会による承認日/Date of IRB
2017 07 19
登録・組入れ開始(予定)日/Anticipated trial start date
2017 09 23
フォロー終了(予定)日/Last follow-up date
2017 11 30
入力終了(予定)日/Date of closure to data entry
2018 12 31
データ固定(予定)日/Date trial data considered complete
2018 12 31
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 05 14
最終更新日/Last modified on
2019 06 25


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037153
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037153

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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