Behaviour, Physiology, Psychology, Therapy
Conditions
Brief summary
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
Detailed 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.
Interventions
BEHAVIORALGuided Imagery Meditation
Audio meditation by Sheri Menelli, for 10-14minutes
BEHAVIORALReligious Recitation
listen to Surah Ar-Rahman for 14 minutes
BEHAVIORALInfant Video with Music
10 minutes of slides show of infant's image and video
BEHAVIORALDistraction with News and Media
10 minutes of phone use
BEHAVIORALControl
All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.
Sponsors
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
It is a within-subject randomized trial is a type of experimental study where each individual is exposed to more than one treatment. In this design, each participant acts as their own control, which helps to control for individual differences and reduces variability.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Relaxation (PR) | 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. |
| Diastolic Blood Pressure (DBP) | 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). |
| Fingertip Temperature (FT) | From enrollment to the end of the 5-session intervention (within 2 weeks). | Pre- and post-measurement of fingertip temperature in degrees Celsius (°C). |
| Breast Milk Cortisol Level | 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). |
| Heart Rate (BPM) | 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). |
| Systolic Blood Pressure (SBP) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbohydrate | 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). |
| Total energy | 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) |
| Fat | 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) |
Countries
Malaysia
Contacts
Primary ContactDr Nurul Husna Mohd Shukri
Backup ContactNazratul Fareha Azman
Outcome results
None listed