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

University of Putra Malaysia (UPM)

Status: Enrolling

Conditions: Behaviour; Therapy; Psychology; Physiology

Treatments: Behavioral: Distraction with News and Media; Behavioral: Infant Video with Music; Behavioral: Control; Behavioral: Religious Recitation; Behavioral: Guided Imagery Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT06864455

vot 1471 (Other Grant/Funding Number)

JKEUPM-2024-205

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 5 patient groups

Guided Imagery Meditation

Experimental group

Description:

Participants will need to listen to the guided imagery meditation tape that was developed by Sheri Menelli in 2004 for breastfeeding mothers as it has been successfully used before.

Treatment:

Behavioral: Guided Imagery Meditation

Religious Recitation

Experimental group

Description:

-Participants will need to listen to Surah Ar-Rahman, which will be used in this study since it has been done previously among pregnant women in the labour process.

Treatment:

Behavioral: Religious Recitation

Infant Video with Music

Experimental group

Description:

The video will be played for 10 minutes duration and mothers will need to hold the phone to look at the slide show of their infant's image and video that will be recorded by the researcher prior session

Treatment:

Behavioral: Infant Video with Music

Distraction with News and Media

Experimental group

Description:

The researcher will instruct mothers to use their phones as they did at home for 10 minutes to measure how this distraction affects the mother's physiology and psychology.

Treatment:

Behavioral: Distraction with News and Media

Control

Experimental group

Description:

No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied.

Treatment:

Behavioral: Control