Type 1 Diabetes MellitusNCT06151821
Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control
A study testing Guided meditation in people with Type 1 Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
The study aims to investigate the effects of Guided Meditation on diabetes-related distress and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will employ a randomized controlled trial design, with participants randomly assigned to either the intervention group (receiving Guided… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Guided meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 3 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent patients aged between 12 to 18 years.
- Confirmed diagnosis of Type 1 diabetes mellitus.
- Hospitalized in the participating medical facility.
- Capable of providing informed consent (for participants aged 18) or providing assent with parental/legal guardian consent (for participants aged 12 to 17).
Who cannot join
- Presence of severe psychiatric disorders or cognitive impairments that may hinder participation in the guided meditation sessions.
- Physical limitations or medical conditions that prevent the safe participation in the intervention or assessment procedures.
- Previously engaged in regular meditation or mindfulness practices, which may confound the results.
- Inability to communicate effectively in the language used for assessments and interventions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control: A Randomized Controlled Trial Among Hospitalized Type 1 Adolescent Diabetic Patients
The study aims to investigate the effects of Guided Meditation on diabetes-related distress and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will employ a randomized controlled trial design, with participants randomly assigned to either the intervention group (receiving Guided Meditation sessions) or the control group (receiving standard care). The primary outcomes measured will be diabetes-related distress levels and glycemic control (HbA1c levels).
Read the detailed description
The researchers hypothesize that the intervention group will experience a reduction in diabetes-related distress and an improvement in glycemic control compared to the control group. The study's findings could suggest how guided meditation could help manage the emotional distress and enhance diabetes management in hospitalized Type 1 adolescent diabetic patients.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Guided meditation
- Keywords
- Type 1 diabetes mellitus, Guided meditation, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided meditationBehavioural
Meditation with guidance
| Study group | Role | What they receive |
|---|---|---|
| Group MTG | Experimental | The intervention arm received Guided Meditation sessions Receives: Behavioral: Guided meditation |
| Group STG | No intervention | The control arm received standard care without any Guided meditation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes distress scale
Diabetes distress scale questionnaire
Measured: Week 1 and Week 13
Secondary outcomes (2)
HbA1c levels
HbA1c levels
Measured: Week 1 and Week 13
Number of hypoglycemic and hyperglycemic episodes
Number of hypoglycemic and hyperglycemic episodes
Measured: Week 1, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Aug 2023
- Primary completion2 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima Abass Tahammal, Shifa International Hospital
- Investigators
- Saima Abbass, MD, MSc, Principal investigator, Shifa hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151821
- Sponsor's protocol ID
- SH-34988383
- Status last verified
- Nov 2023
- First submitted
- 2 Aug 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control: A Randomized Controlled Trial Among Hospitalized Type 1 Adolescent Diabetic Patients
- ClinicalTrials.gov ID
- NCT06151821
- Acronym / sponsor ID
- SH-34988383
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Guided meditation, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the effects of Guided Meditation on diabetes-related distress and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will employ a randomized controlled trial design, with participants randomly assigned to either the intervention group (receiving Guided Meditation sessions) or the control group (receiving standard care). The primary outcomes measured will be diabetes-related distress levels and glycemic control (HbA1c levels).
Detailed description
The researchers hypothesize that the intervention group will experience a reduction in diabetes-related distress and an improvement in glycemic control compared to the control group. The study's findings could suggest how guided meditation could help manage the emotional distress and enhance diabetes management in hospitalized Type 1 adolescent diabetic patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group MTG | Experimental | Behavioral: Guided meditationThe intervention arm received Guided Meditation sessions |
| Group STG | No intervention | –The control arm received standard care without any Guided meditation sessions |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent patients aged between 12 to 18 years.
- Confirmed diagnosis of Type 1 diabetes mellitus.
- Hospitalized in the participating medical facility.
- Capable of providing informed consent (for participants aged 18) or providing assent with parental/legal guardian consent (for participants aged 12 to 17).
Key exclusion criteria (4 listed)
- Presence of severe psychiatric disorders or cognitive impairments that may hinder participation in the guided meditation sessions.
- Physical limitations or medical conditions that prevent the safe participation in the intervention or assessment procedures.
- Previously engaged in regular meditation or mindfulness practices, which may confound the results.
- Inability to communicate effectively in the language used for assessments and interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided meditationMeditation with guidance | Behavioural | Group MTG |
Primary outcome
Diabetes distress scale
Time frame: Week 1 and Week 13
Diabetes distress scale questionnaire
2 secondary outcomes
HbA1c levels
Time frame: Week 1 and Week 13
Number of hypoglycemic and hyperglycemic episodes
Time frame: Week 1, 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saima Abbass, MD, MSc principal investigator
Shifa hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided meditation in people with Type 1 Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes distress scale (time frame: Week 1 and Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.