NCT02574871

Brief Summary

This study consists of psychological and biological data collection for identification of the chronic stress presence in healthy adult subjects. The psychological data collected were the results provided by three different instruments: ISSL, PSS and SRRS. The biological data collected were the blood pressure, the skin temperature, the galvanic skin response, and the heart rate variability in time and frequency domain.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

October 9, 2015

Last Update Submit

October 13, 2015

Conditions

Keywords

StressChronic stressPerceived stressPsychological distress

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability (HRV)

    Short-term heart rate variability recording, according to recommendations of the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology

    5 minutes

Secondary Outcomes (6)

  • Blood pressure measurement (BP)

    1 minute

  • Temperature measurement (ST)

    5 minutes

  • Galvanic skin response (GSR)

    5 minutes

  • Stress assessment (ISSL)

    10 minutes

  • Perceived stress (PSS)

    5 minutes

  • +1 more secondary outcomes

Study Arms (1)

Single Group

Psychological and biological data collection

Other: Psychological and biological data collection

Interventions

Psychological and biological data collection for identification of the chronic stress presence

Single Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

undergraduate students

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Presence of any disease
  • Use of medications to control blood pressure
  • Use of anxiety medications and antidepressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

    PMID: 8598068BACKGROUND
  • Zhai J, Barreto A. Stress detection in computer users based on digital signal processing of noninvasive physiological variables. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:1355-8. doi: 10.1109/IEMBS.2006.259421.

    PMID: 17946041BACKGROUND
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND
  • Holmes TH, Rahe RH. The Social Readjustment Rating Scale. J Psychosom Res. 1967 Aug;11(2):213-8. doi: 10.1016/0022-3999(67)90010-4. No abstract available.

    PMID: 6059863BACKGROUND
  • Bandeira DR, Pawlowski J, Goncalves TR, Hilgert JB, Bozzetti MC, Hugo FN. Psychological distress in Brazilian caregivers of relatives with dementia. Aging Ment Health. 2007 Jan;11(1):14-9. doi: 10.1080/13607860600640814.

    PMID: 17164153BACKGROUND

Study Officials

  • Annie F Frere Slaets, PhD

    University of Mogi das Cruzes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 14, 2015

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10