Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction
Primary Purpose
Psychological Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mindfulness Based stress reduction
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Stress focused on measuring psychological stress mobile phone addiction
Eligibility Criteria
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.
Sites / Locations
- Zia-Un Nisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mindfulness based stress reduction
Relaxation Exercise
Arm Description
mindfulness based stress reduction intervention was used to treat psychological and addiction problems of the individuals
the control group was provided with the relaxation technique.
Outcomes
Primary Outcome Measures
COVID-19 related Stress
COVID-19 related stress scale(<5 minimum, >72 Maximum)
anxiety and depression
hospitalized anxiety and depression scale (<7 minimum, >21 Maximum)
Secondary Outcome Measures
mobile phone addiction
smartphone addiction scale (33 minimum, 198maximum)
Full Information
NCT ID
NCT05415280
First Posted
February 24, 2022
Last Updated
June 10, 2022
Sponsor
Fatima Jinnah Women University
1. Study Identification
Unique Protocol Identification Number
NCT05415280
Brief Title
Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction
Official Title
Impact of Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction During Pandemic: A Randomized Control Trails
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatima Jinnah Women University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
psychological stress mobile phone addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based stress reduction
Arm Type
Experimental
Arm Description
mindfulness based stress reduction intervention was used to treat psychological and addiction problems of the individuals
Arm Title
Relaxation Exercise
Arm Type
Other
Arm Description
the control group was provided with the relaxation technique.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based stress reduction
Intervention Description
The aim of the psychological intervention to reduce the mental health problems of the participants.
Primary Outcome Measure Information:
Title
COVID-19 related Stress
Description
COVID-19 related stress scale(<5 minimum, >72 Maximum)
Time Frame
35 minutes
Title
anxiety and depression
Description
hospitalized anxiety and depression scale (<7 minimum, >21 Maximum)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
mobile phone addiction
Description
smartphone addiction scale (33 minimum, 198maximum)
Time Frame
35 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zia-un nisa
Phone
03335248819
Email
ziaunnisa95@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zia-un Nisa
Organizational Affiliation
assisstant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zia-Un Nisa
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigator has not plan to share data without taking permission from the study participants.
Learn more about this trial
Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction
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