NCT04998708

Brief Summary

the aim of this study is to investigate the effect of relaxation techniques on immune biomarkers and disease severity and progression in patients with COVID-19 and the period to which these changes last.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

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

December 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
Last Updated

March 21, 2022

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

August 8, 2021

Last Update Submit

March 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Immune biomarkers

    5 months

  • Wisconsin Upper Respiratory Symptom Survey

    5 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group performed two types of relaxation techniques, that have shown their positive effects on immune functions, including progressive muscle relaxation exercise (PMRs)16 and cognitive-behavioral stress management (CBSM). We used two types of relaxation techniques to produce maximum effects of relaxation techniques within the limited period of COVID-19 quarantine (2 weeks). the control groups did not receive any treatment during the study; however, they were treated afterwards.

Other: Relaxation technique

Control

NO INTERVENTION

Interventions

The intervention group performed two types of relaxation techniques, that have shown their positive effects on immune functions, including progressive muscle relaxation exercise (PMRs)16 and cognitive-behavioral stress management (CBSM)32. We used two types of relaxation techniques to produce maximum effects of relaxation techniques within the limited period of COVID-19 quarantine (2 weeks). the control groups did not receive any treatment during the study; however, they were treated afterwards.

Intervention

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A recent mild or moderate COVID-19 with no or low-grade fever 99.5- 100.94 °F (37.5-38.3 °C)

You may not qualify if:

  • Any patient was not hospitalized and had high-grade fever \<100.94 °F (\<38.3 °C) or other chronic diseases such as heart problems, hypertension, or diabetes. Women how were using contraceptives were excluded because contraceptives decrease immune functions and might affect the subjectivity to autoimmune disorders with marked increases in risk for various autoimmune disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Gelisim University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Alawna M, Mohamed AA. An integrated intervention combining cognitive-behavioural stress management and progressive muscle relaxation improves immune biomarkers and reduces COVID-19 severity and progression in patients with COVID-19: A randomized control trial. Stress Health. 2022 Dec;38(5):978-988. doi: 10.1002/smi.3151. Epub 2022 Apr 20.

MeSH Terms

Conditions

COVID-19

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 8, 2021

First Posted

August 10, 2021

Study Start

December 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 21, 2022

Record last verified: 2021-08

Locations