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NCT Number: NCT06864455

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

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

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Key information

Conditions

Behaviour Behavior Physiology Psychology Therapy

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor

Serdang, Selangor, 43400, Malaysia

Location status: Recruiting

Location contact

Dr Zurina Zainuddin Dr Zurina Zainuddin

CONTACT

[email protected]

+603-9769261

About this study

The trial aims to recruit 30 mothers of premature infants who are born between 28 and 35 weeks, which falls under the categories of early and mid-preterm. Participants will be recruited among mothers aged between 18 and 49 who are non-smokers, with no medical condition that could affect breastfeeding, and also those who are not taking any psychiatric medication, and those who are not diagnosed with mental illness. This trial also aims to recruit Muslim mothers, since one of the interventions is Religious Recitation which focuses on Qur'anic verses.

The participants will be identified through recent hospital data on premature infants born between 28 to 35 weeks gestation and through a face-to-face approach. The study information sheet will be given to interested mothers. Eligible mothers will be given consent forms after assessing the inclusion and exclusion criteria for mothers and infants. The participants will be enrolled in the study and randomized using a computerized random number generator, where the participants cannot choose which intervention to test first. One person who had no contact with the participants will do randomization five times for each participant since four interventions and controls were involved.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

( Mothers)

  • Malaysian women of reproductive age (18-49 years)
  • Muslim
  • Non-smoker
  • Understand English or Malay
  • Currently breastfeed their infants
  • Mothers of infants born in gestational age (28 weeks- 35 weeks)
  • No medical conditions that can affect infant feeding.

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Heart Rate (BPM)

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

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

  2. Systolic Blood Pressure (SBP)

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

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

  3. Diastolic Blood Pressure (DBP)

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

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

  4. Fingertip Temperature (FT)

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

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

  5. Breast Milk Cortisol Level

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

    Pre- and post-measurement of cortisol levels in breast milk, typically expressed in nanograms per milliliter (ng/mL).

  6. Perceived Relaxation (PR)

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

    Pre- and post-measurement of perceived relaxation levels, using a 10 cm Visual Analogue Scale (VAS). The scale ranges from 0 to 10 cm, where 0 cm (on the left) represents "completely unrelaxed" and 10 cm (on the right) represents "completely relaxed." Participants will mark a point on the scale that reflects their level of relaxation at the specified time.

Secondary outcomes

  1. Fat

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

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

  2. Carbohydrate

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

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

  3. Total energy

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Nurul Husna Mohd Shukri

CONTACT

[email protected]

+603-97692963

Nazratul Fareha Azman

CONTACT

[email protected]

+60134974704

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Registry information

Official study title

"Effects of a Relaxation Intervention on Physiological and Psychological Outcomes Among Mothers of Preterm Infants At Hospital Sultan Abdul Aziz Shah : a Within-subject Randomized Trials"

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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