- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07601360
Nature-based Outdoor Activities for Promoting Stress Resilience in Employees
The goal of this randomized controlled trial (RCT) is to assess the impact of a nature-based workplace intervention on stress resilience in full-time employees in Hong Kong.
The main question it aims to answer is: Does a nature-based group activity intervention improve stress resilience in employees?
Researchers will compare the intervention group (participants who attend three nature-based group sessions) to the control group (participants who receive no intervention and continue their usual routines) to see if the nature-based activities lead to greater improvements in stress resilience compared to no intervention.
Participants will complete baseline measurements (questionnaires, blood pressure, and heart rate variability) one week before the first session.
If assigned to the intervention group: Attend three one-hour group sessions at a nearby park (once every two weeks, 8:00-9:00 AM) involving mindful walking, gentle movement, nature observation, breathing exercises, and group reflection
If assigned to the control group: Continue their usual daily routines with no specific activities
Complete follow-up assessments (same measurements as baseline): immediately after the second session and one week after the third session
Primary measurement: HRV Secondary measurements: Blood pressure, Perceived stress scale (PSS) and the Difficulties in emotion regulation scale (DERS).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants:
The participants of this study will be recruited from full-time employees at diverse corporate settings in Hong Kong. The sample size was determined using G*Power software. With a medium effect size (f = 0.25), an alpha level of 0.05, a desired power of 0.80, and a correlation among repeated measures of 0.50, the required total sample size was calculated to be 34. Accounting for an anticipated 20% attrition rate, the investigator aims to recruit 43 participants.
Study procedure:
This study uses a randomized controlled trial (RCT) to assess the impact of the workplace intervention on stress resilience in employees. To ensure allocation concealment, randomization will be performed by a third party (a program instructor who was not involved in participant recruitment or outcome assessment). Participants and researchers will be blinded to group assignment. The experimental procedure will be explained to potential participants in a recruitment poster, which required them to send their informed consent before participating. All participants will be invited to complete baseline measurements one week before the start of the first intervention session. Baseline measurements will take approximately 15-20 mins. Once the participants complete the questionnaire, the investigator will ask them to measure BP and HRV. All measurements will be taken after a 5-minute rest period in a seated position with back support, feet flat on the floor, and no talking. Participants will complete follow-up assessments at three time points using the same measures as at baseline (T1): T2 (immediately after the second session) and T3 (one week after the third session).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kowloon
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Hong Kong, Kowloon, Hong Kong
- The Hong Kong Polytechnic University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Over 18 years
- Full-time employees
Exclusion Criteria:
- part-time employees
- individuals employed for less than six months
- those with symptoms of heart disease
- participants over 65 years of age
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Outdoor activity group
Three days outdoor activity group
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After randomization, participants in the intervention group will attend three group activity sessions, while those in the control group will receive no intervention and were instructed to continue their usual daily routines.
The group activity sessions will be conducted at a nearby park for one hour each session (8:00-9:00 AM).
Sessions will be held once every two weeks, for a total of three sessions.
Each session will be contained various group activities, such as mindful walking, gentle movement, nature observation, breathing exercises and group reflection.
These group activities led by facilitators aims to increase social interaction and nature exposure.
Participants in the control group were not asked to attend specific activities.
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Aucune intervention: No-treatment control group
No specific activities required
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heart rate variability (HRV)
Délai: From enrollment to the end of treatment at 8 weeks
|
HRV will be measured using SA-3000P (MEDICORE, Korea).
The sensor is positioned with a strap around the fingertip of the middle finger on one of the participants hands.
This study will use RMSSD (ms), SDNN (ms) and LF/HF ratio as HRV indicators to evaluate the stress response.
In HRV analysis, higher RMSSD values indicate greater parasympathetic activity, reflecting relaxation and recovery.
Similarly, Higher SDNN values indicate greater overall HRV, reflecting better autonomic nervous system flexibility.
In contrast, higher LF/HF ratio values indicate sympathetic dominance, reflecting stress and arousal.
This will be measured three times: at baseline (T1), immediately after the second session (T2), and one week after the third session (T3).
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From enrollment to the end of treatment at 8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood pressure (BP)
Délai: From enrollment to the end of treatment at 8 weeks
|
BP will be measured using a digital automatic BP monitor (PASESA AVE-2000, Japan) with an arm cuff placed on the non-dominant arm at heart level.
Normal systolic blood pressure (SBP) is defined as 120-139 mmHg, and normal diastolic blood pressure (DBP) as 80-89 mmHg.
The incidence of elevated BP (SBP ≥140 mmHg or DBP ≥90 mmHg) in follow-up, rather than the diagnosis of hypertension, will be used as an outcome indicator of changes in stress levels.
This will be measured three times: at baseline (T1), immediately after the second session (T2), and one week after the third session (T3).
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From enrollment to the end of treatment at 8 weeks
|
|
Perceived stress scale (PSS)
Délai: From enrollment to the end of treatment at 8 weeks
|
PSS measures the degree to which individuals perceive their lives as stressful.
A total of 14 items (e.g., 'In the last three months, how often have you been upset because of something that happened unexpectedly?
'), each of which uses a Likert scale ranging from 1 (never) to 5 (very often), are rated by participants.
Higher score indicates higher stress levels.
This will be measured three times: at baseline (T1), immediately after the second session (T2), and one week after the third session (T3).
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From enrollment to the end of treatment at 8 weeks
|
|
Difficulties in emotion regulation scale (DERS)
Délai: From enrollment to the end of treatment at 8 weeks
|
DERS assesses emotion regulation problems.
A total of 18 items (e.g., 'I have difficulty making sense out of my feelings') are rated by participants using a Likert scale ranging from 1 (almost never) to 5 (almost always).
Higher scores indicate greater emotion regulation difficulties.
This will be measured three times: at baseline (T1), immediately after the second session (T2), and one week after the third session (T3).
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From enrollment to the end of treatment at 8 weeks
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Eun Yeong Choe, PhD, The Chinese University of Hong Kong, Shenzhen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CUHKShenzhen_2
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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