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

08 May 2020

The date of last modification

May 08, 2020



Application Summary


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


Trial Details


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

  1. 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.

  2. 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)

  1. 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.

  2. 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.

  3. Let go of your tensed muscles relax with exhaling slowly and relax completely.

  4. 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.

    1. Work your way down to both hands and arms and the both legs.
    2. Quickly focusing on each group one after the other, with practice you can relax your body like ‘liquid relaxation’ poured on your head and it flowed down and completely covered you. Once you are able to relax our body from head to toe, your mind.

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


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Faculty of Medical Sciences, University of Sri Jayawardenepura

Gangodawila, Nugegoda



Secondary study sponsor (If any)

None





Trial Completion details


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