Clinical trial NCT06476730: Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes
Official title: Effects of Telerehabilitation Exercise Program on Psychological Health and Delivery Outcomes in Women With Gestational Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Gestational Diabetes
Maternal Psychological Distress
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 62
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups, experimental and control
Primary purpose: TREATMENT

Brief summary: Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Women with gestational diabetes often feel more anxious and stressed and have a higher risk of depression during and after pregnancy. This study will explore how telerehabilitation can reduce anxiety and depression and show how exercise can improve the health of pregnant women with gestational diabetes.

Detailed description: The diagnosis of GDM can be unexpected and distressing, leading to feelings of sadness and hopelessness.Women with GDM are at a higher risk of experiencing prenatal and postnatal depression, which can affect their overall well-being and ability to care for their newborn. Regularly checking blood sugar levels, changing diet, and possibly using medication or insulin can be overwhelming. This constant effort and worry about complications can cause a lot of anxiety and stress. Many pregnant women with GDM might not fully understand how exercise can help control their blood sugar levels and improve their overall well-being. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve psychological symptoms in participants with GDM.

The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving psychological health.

Eligibility criteria: Inclusion Criteria:

* Women aged 20 to 35 years
* Gestational age between 20-28weeks
* diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
* Primigravida and multigravida
* able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
* Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
* Who signed informed consent

Exclusion Criteria:

* Previously diagnosed T1DM or T2DM
* High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
* Patients taking insulin regularly.
* Patients with fetal anomalies diagnosed at 20 th week.
* Multiple gestation (twin or triplets).

Primary outcomes:
measure: Center of Epidemiologic studies depression scale (CES-D)
timeFrame: changes from baseline to 8th week
measure: Strait trait anxiety inventory (STAI)
timeFrame: changes from baseline to 8th week
Secondary outcomes:
measure: Time of delivery
timeFrame: At the time of delivery
measure: Mode of delivery
timeFrame: At the time of delivery
measure: Incidence of instrumental delivery
timeFrame: At the time of delivery
measure: Incidence of shoulder dystocia
timeFrame: At the time of delivery
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railways Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: AlKhidmat Razi Hospital,Rawalpindi
state: Punjab
Study officials:
affiliation: Riphah International University, Islamabad, Pakistan
name: Huma Riaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: