Home » Trials » SLCTR/2020/013
Prevalence of depression, anxiety and stress among primigravida antenatal mothers in Badulla district and effectiveness of a progressive muscle relaxation therapy in improving their anxiety, stress and pregnancy outcome
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SLCTR Registration Number
SLCTR/2020/013
Date of Registration
The date of last modification
Sep 10, 2020
Scientific Title of Trial
Prevalence of depression, anxiety and stress among primigravida antenatal mothers in Badulla district and effectiveness of a progressive muscle relaxation therapy in improving their anxiety, stress and pregnancy outcome
Public Title of Trial
Effectiveness of a progressive muscle relaxation therapy in improving anxiety, stress and selected pregnancy outcomes among primigravida antenatal mothers in Badulla District: A community based cluster randomized controlled trial
Disease or Health Condition(s) Studied
Anxiety and stress
Scientific Acronym
None
Public Acronym
None
Brief title
Prevalence of depression, anxiety and stress among primigravida antenatal mothers in Badulla district and effectiveness of a progressive muscle relaxation therapy in improving their anxiety, stress and pregnancy outcome
Universal Trial Number
U1111-1228-2415
Any other number(s) assigned to the trial and issuing authority
ERC 19 – 013, ERC, SLMA
What is the research question being addressed?
Does progressive muscle relaxation therapy vs non therapy improve anxiety, stress and pregnancy outcome of primi mothers?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting and randomization: Antenatal clinics in 36 public health midwives (PMH) areas in six selected MOH areas in Badulla district. Randomly 18 PHM areas will be selected from the three selected MOH areas for the intervention arm and 18 PHM areas for the control arm will be selected from another three MOH areas which are not adjacent to the intervention arm. 144 mothers each will be randomly selected for intervention and 144 mothers control groups. The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) will be used to detect mothers with anxiety and stress.
Intervention Progressive Muscle Relaxation (PMR) therapy
Field Facilitators (Public Health Midwives, FF) will be trained by a Psychotherapist and will deliver the intervention
Steps of the PMR are as follows; 1. Find convenient time (around 30 minutes)
Sit and make yourself comfortable (After finding a quiet place and several free minutes to practice progressive muscle relaxation, sit or lie down and make yourself comfortable.
Start with the face – Tense all the muscles in the face and scalp, tightly close your eyes, clench your teeth. Hold this for the count of eight as you inhale.
Let go of your tensed muscles relax with exhaling slowly and relax completely.
Then move to the neck. Completely tense your neck and shoulders, again inhaling and counting to eight. Then exhale and relax. Again, this step can be repeated until you feel absolutely relaxed in this area.
The study participants will be trained on PMR therapy using a video presentation will be asked to carry out this progressive muscle relaxation technique all days of the week for twenty minutes twice daily at home for a duration of six weeks. The participants will be given a daily performance diary to record the date and time they carried out the process at home. Weekly re enforcements will be done through phone and home visits by the PI.
Both the intervention and control group primi mothers will be given a general health education lecture.
Except for the fact that this group of mothers will not participate in the progressive muscle relaxation therapy programme, they will also be visited at home by the PI/FFs at least in one occasion during the period of study.
Both groups will be given routine care, that means normal pregnancy care in the field and by the hospital which we provided for a pregnant mother in their pregnancy period till their delivery.
The video used to train mothers on PMR therapy includes the following • How PMR will reduce the impact of stress and anxiety during pregnancy • How to do the PMR – Explaining the steps in doing the relaxation therapy • Benefits of progressive muscle relaxation
3) Blinding: Data collectors will be blinded
Inclusion criteria
Primi mothers,
Above 18 years of age
In latter stage of the second trimester (20 to 28 weeks period of gestation)
Uncomplicated singleton pregnancy
Residing in the same MOH area till their delivery and postpartum period
Exclusion criteria
Primi mothers who are,
Diagnosed with any psychiatric illness
Having any physical or learning disability
Practicing any other relaxation technique
Having any other medical or obstetric complications
Primary outcome(s)
1.
Anxiety and stress scores of the primi mothers in both groups using Depression, Anxiety and stress scale – 21 (DASS -21) |
[ At recruitment and six weeks after introducing the intervention ] |
Secondary outcome(s)
1.
Mode of delivery, premature delivery, prolonged rupture of the membranes, prolonged labour, gestational age at birth, birth weight and apgar score will be assessed using a questionnaire developed in-house. |
[ At post partum one month (one month after the delivery ] |
Target number/sample size
288 (144 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-05-15
Anticipated end date
2020-09-15
Date of first enrollment
2020-05-15
Date of study completion
Recruitment status
Recruiting
Funding source
Self funded
Regulatory approvals
Status
Approved
Date of Approval
2020-01-17
Approval number
ERC 19 – 013
Details of Ethics Review Committee
Name: | Ethics Review Committee of the Sri Lanka Medical Association |
Institutional Address: | The Sri Lanka Medical Association, Wijerama House, 06 Wijerama Mawatha, Colombo 00700 |
Telephone: | +94112693324 |
Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.N.M.C. Lakshrieni Nishshanka
Medical Officer
Medical Officer of Health,
Medical Officer of Health Office, Bandarawela.
0572222275
0711749631
0572222278
nmclakshrieni@gmail.com
Contact Person for Public Queries
Prof.C.S.E.Goonewardene
Professor in Community Medicine
Faculty of Medical Sciences, University of Sri Jayawardenepura, Gangodawila, Nugegoda
0112803191
0777350705
0112801480
sampatha4@yahoo.co.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. Study protocol and statistical analysis plan will also be available. Data will be available immediately following publication, no end date. The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose in order to achieve the aims in an approved proposal. Data will be available by directing the proposals to nmclakshrieni@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at ((provide link to proposed IPD database)
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results