NCT04167852

Brief Summary

This study represents a 3-arm, randomized controlled trial to investigate the impact of a validated 10-minute mindfulness intervention delivered via mobile technology on postoperative bariatric patients. The investigators hypothesize that participation in a brief, daily mindfulness intervention will improve outcomes in bariatric patients and use of mobile technology will facilitate patient compliance.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

October 31, 2019

Last Update Submit

June 18, 2021

Conditions

Opioid UseBariatric Surgery CandidatePain, Postoperative

Keywords

Painpostoperativemeditationopioid usebariatric

Outcome Measures

Primary Outcomes (2)

  • Daily post-operative patient reported pain scores

    Daily post-operative patient reported pain scores via the validated Numeric Rating Scale (NRS). The higher number indicates more pain.

    30 days after discharge

  • Daily post-operative narcotic consumption

    Daily post-operative narcotic consumption reported as morphine equivalent dose (MED).

    30 days after discharge

Secondary Outcomes (3)

  • Patient satisfaction: (HCAHPS) scores

    visit 3 (4 weeks after operation)

  • Weight loss

    pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months

  • Bariatric-specific quality of life (BQL)

    pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months

Study Arms (3)

Treatment group

EXPERIMENTAL

Subject to receive daily short message service (SMS) text message with a link to a mindfulness intervention.

Behavioral: Daily text messageBehavioral: Mindfulness intervention

Text group

EXPERIMENTAL

Subject to receive daily text message but without the link to the mindfulness intervention.

Behavioral: Daily text message

Standard of Care group

NO INTERVENTION

Subject will not receive any text message reminders or the mindfulness meditation intervention.

Interventions

Daily text messageBEHAVIORAL

Patients will receive a daily text message stating how many days they have until or since their surgery.

Text groupTreatment group
Mindfulness interventionBEHAVIORAL

Patients will receive a link to mindfulness meditation intervention for ten minutes.

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years of age
  • BMI \> 40 or a BMI \> 35 with the presence of at least 1 comorbidity (hypertension, diabetes, sleep apnea syndrome, coronary artery disease, dyslipidemia, osteoarthritis, secondary infertility in females)
  • Ownership of smart phone (iOS or Android operating system) with SMS text messaging capabilities
  • Ability to read and understand English
  • Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by Cedars Sinai Medical Center

You may not qualify if:

  • Patients with contraindications to abdominal surgery and/or general anesthesia
  • Patients will be screened for PTSD preoperatively. Patients with diagnosable PTSD will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yufei Chen, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 19, 2019

Study Start

November 21, 2019

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

US(1)