- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415280
Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction
June 10, 2022 updated by: Zia-un-nisa, Fatima Jinnah Women University
Impact of Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction During Pandemic: A Randomized Control Trails
The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In the current study the data was collected from the young adults (age range 19-35 years).
The high scorer from the sample selected from the participants in both control and experimental groups.
furthermore, the mindfulness based stress reduction intervention was given to the experimental group.
The mindfulness based stress reduction intervention comprised eight weeks period.
After the provision of intervention the data for the second phase would be collected.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zia-un nisa
- Phone Number: 03335248819
- Email: ziaunnisa95@gmail.com
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Zia-Un Nisa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The participants fulfil the age criteria, students from public and private universities, and provided signed informed consent.
Exclusion Criteria:
- Participant suffering from chronic physical or psychological disorder. In addition participant who experience death of loved ones during COVID-19 pandemic.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness based stress reduction
mindfulness based stress reduction intervention was used to treat psychological and addiction problems of the individuals
|
The aim of the psychological intervention to reduce the mental health problems of the participants.
|
OTHER: Relaxation Exercise
the control group was provided with the relaxation technique.
|
The aim of the psychological intervention to reduce the mental health problems of the participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 related Stress
Time Frame: 35 minutes
|
COVID-19 related stress scale(<5 minimum, >72 Maximum)
|
35 minutes
|
anxiety and depression
Time Frame: 15 minutes
|
hospitalized anxiety and depression scale (<7 minimum, >21 Maximum)
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mobile phone addiction
Time Frame: 35 minutes
|
smartphone addiction scale (33 minimum, 198maximum)
|
35 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: zia-un Nisa, Assisstant professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
August 1, 2022
Primary Completion (ANTICIPATED)
October 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
June 10, 2022
First Posted (ACTUAL)
June 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 14, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBSR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigator has not plan to share data without taking permission from the study participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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