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Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)

ConditionsBehaviourPsychologyPhysiologyTherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversiti Putra Malaysia

About this trial

This study is designed to compare the effects of four relaxation interventions on both physiological and psychological outcomes in lactating mothers of preterm infants. The interventions being tested include:

* Guided Imagery Meditation (GIM) * Religious Recitation (RR) * Infant Video with Music * Distraction with News and Media * A Control session

The primary objectives of the study are to evaluate and compare how these different relaxation techniques influence the physiological and psychological well-being of mothers and identify which intervention is most effective for lactating mothers who deliver prematurely.

The main research questions are:

1. How do different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) affect physiological and psychological outcomes when measured within the same participants? 2. Are there significant differences in physiological and psychological outcomes when participants are exposed to different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) within the same group? 3. Among the interventions, which one demonstrates the most beneficial effects on physiological and psychological outcomes within the same participants?

Study Design:

Each participant will be exposed to five different sessions (one for each intervention), with a gap of 1-2 days between sessions. The interventions will be administered as follows:

* Guided Imagery Meditation (GIM) * Religious Recitation (RR) * Infant Video with Music * Distraction with News and Media * A Control session

Expected Outcomes:

This study will assess the following physiological and psychological outcomes:

Physiological changes:

* Heart Rate (HR) * Systolic Blood Pressure (SBP) * Diastolic Blood Pressure (DBP) * Fingertip Temperature (FT) * Breast milk cortisol concentration

Psychological changes:

•. Perceived Relaxation

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Malaysian women of reproductive age (18-49 years)

Muslim

Non-smoker

Understand English or Malay

Disqualifiers

Taking psychiatric medication and being diagnosed with mental illness.

Mothers are on medication that contradicts breastfeeding (eg: under medication HIV/AIDS)

Plan to formula feed or mix feeding their infants.

Mothers of infants with illness that could affect breastfeeding and growth (respiratory issues, gastrointestinal issues, feeding difficulties, neurological disorder, etc)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Guided Imagery Meditation

    Behavioral

    Audio meditation by Sheri Menelli, for 10-14minutes

  • Religious Recitation

    Behavioral

    listen to Surah Ar-Rahman for 14 minutes

  • Infant Video with Music

    Behavioral

    10 minutes of slides show of infant's image and video

  • Distraction with News and Media

    Behavioral

    10 minutes of phone use

  • Control

    Behavioral

    All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.

Treatment groups

15 Participants
are divided into 5 treatment groups
Group A: Guided Imagery MeditationExperimental treatment 1 intervention
Group B: Religious RecitationExperimental treatment 1 intervention
Group C: Infant Video with MusicExperimental treatment 1 intervention
Group D: Distraction with News and MediaExperimental treatment 1 intervention
Group E: ControlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Heart Rate (BPM)

Pre- and post-measurement of heart rate in beats per minute (BPM).

Time frame
From enrollment to the end of the 5-session intervention (within 2 weeks).
2

Systolic Blood Pressure (SBP)

Pre- and post-measurement of systolic blood pressure in millimeters of mercury (mmHg).

Time frame
From enrollment to the end of the 5-session intervention (within 2 weeks).
3

Diastolic Blood Pressure (DBP)

Pre- and post- measurement of diastolic blood pressure in millimeters of mercury (mmHg).

Time frame
From enrollment to the end of the 5-session intervention (within 2 weeks).
4

Fingertip Temperature (FT)

Pre- and post-measurement of fingertip temperature in degrees Celsius (°C).

Time frame
From enrollment to the end of the 5-session intervention (within 2 weeks).

Secondary outcomes

1

Fat

Pre- and post- measurement of milk fat content in grams per 100 milliliters (g/100 mL)

Time frame
From enrollment to the end of the 5-session intervention (within 2 weeks).
2

Carbohydrate

Pre- and post- measurement of milk carbohydrate content in grams per 100 milliliters (g/100 mL).

Time frame
Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
3

Total energy

Pre- and post-measurement of total energy content in kilocalories per 100 milliliters (kcal/100 mL)

Time frame
Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Putra Malaysia

Lead sponsor

European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Collaborator

Source ClinicalTrials.gov
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