BehaviourNCT06864455
Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)
A study testing Guided Imagery Meditation, Religious Recitation and Infant Video with Music in people with Behaviour and Psychology, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behaviour, Psychology, Physiology
- What is being tested?
- Guided Imagery Meditation, Religious Recitation and Infant Video with Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteMalaysia
- Study dates
- 5 Jan 2025to 21 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor
Serdang, Selangor, 43400
About this study
Official 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"
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
Read more
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:
- 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?
- 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?
- 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
Read the 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.
- Conditions
- Behaviour, Psychology, Physiology, Therapy
- Being tested
- Guided Imagery Meditation, Religious Recitation, Infant Video with Music, Distraction with News and Media, Control
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery MeditationBehavioural
Audio meditation by Sheri Menelli, for 10-14minutes
Religious RecitationBehavioural
listen to Surah Ar-Rahman for 14 minutes
Infant Video with MusicBehavioural
10 minutes of slides show of infant's image and video
Distraction with News and MediaBehavioural
10 minutes of phone use
ControlBehavioural
All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery Meditation | Experimental | 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. Receives: Behavioral: Guided Imagery Meditation |
| Religious Recitation | Experimental | -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. Receives: Behavioral: Religious Recitation |
| Infant Video with Music | Experimental | 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 Receives: Behavioral: Infant Video with Music |
| Distraction with News and Media | Experimental | 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. Receives: Behavioral: Distraction with News and Media |
| Control | Experimental | No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (BPM)
Pre- and post-measurement of heart rate in beats per minute (BPM).
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Systolic Blood Pressure (SBP)
Pre- and post-measurement of systolic blood pressure in millimeters of mercury (mmHg).
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Diastolic Blood Pressure (DBP)
Pre- and post- measurement of diastolic blood pressure in millimeters of mercury (mmHg).
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Fingertip Temperature (FT)
Pre- and post-measurement of fingertip temperature in degrees Celsius (°C).
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Breast Milk Cortisol Level
Pre- and post-measurement of cortisol levels in breast milk, typically expressed in nanograms per milliliter (ng/mL).
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Perceived Relaxation (PR)
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.
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Secondary outcomes (3)
Fat
Pre- and post- measurement of milk fat content in grams per 100 milliliters (g/100 mL)
Measured: From enrollment to the end of the 5-session intervention (within 2 weeks).
Carbohydrate
Pre- and post- measurement of milk carbohydrate content in grams per 100 milliliters (g/100 mL).
Measured: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
Total energy
Pre- and post-measurement of total energy content in kilocalories per 100 milliliters (kcal/100 mL)
Measured: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start5 Jan 2025
- Primary completion31 Dec 2025
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Responsible party
- Principal investigator, Nurul Husna Binti Mohd Shukri, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864455
- Sponsor's protocol ID
- JKEUPM-2024-205
- Other IDs
- vot 1471
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results, including aggregated data, will be shared to contribute to broader scientific understanding. However, due to privacy and confidentiality concerns, individual participant data will not be shared. Only de-identified, summary-level data (e.g., group results, statistical analyses) will be made available to the public or other researchers.
Publications
Yu J, Wells J, Wei Z, Fewtrell M. Effects of relaxation therapy on maternal psychological state, infant growth and gut microbiome: protocol for a randomised controlled trial investigating mother-infant signalling during lactation following late preterm and early term delivery. Int Breastfeed J. 2019 Dec 16;14:50. doi: 10.1186/s13006-019-0246-5. eCollection 2019.
PubMed 31889973Yu J, Wells J, Wei Z, Fewtrell M. Randomized Trial Comparing the Physiological and Psychological Effects of Different Relaxation Interventions in Chinese Women Breastfeeding Their Healthy Term Infant. Breastfeed Med. 2019 Jan/Feb;14(1):33-38. doi: 10.1089/bfm.2018.0148. Epub 2018 Oct 23.
PubMed 30351172Mohd Shukri NH, Wells JCK, Fewtrell M. The effectiveness of interventions using relaxation therapy to improve breastfeeding outcomes: A systematic review. Matern Child Nutr. 2018 Apr;14(2):e12563. doi: 10.1111/mcn.12563. Epub 2017 Nov 6.
PubMed 29105966Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
PubMed 31161202Rafique R, Anjum A, Raheem SS. Efficacy of Surah Al-Rehman in Managing Depression in Muslim Women. J Relig Health. 2019 Apr;58(2):516-526. doi: 10.1007/s10943-017-0492-z.
PubMed 28900859Nomkin LG, Gordon I. The relationship between maternal smartphone use, physiological responses, and gaze patterns during breastfeeding and face-to-face interactions with infant. PLoS One. 2021 Oct 8;16(10):e0257956. doi: 10.1371/journal.pone.0257956. eCollection 2021.
PubMed 34624025Keith DR, Weaver BS, Vogel RL. The effect of music-based listening interventions on the volume, fat content, and caloric content of breast milk-produced by mothers of premature and critically ill infants. Adv Neonatal Care. 2012 Apr;12(2):112-9. doi: 10.1097/ANC.0b013e31824d9842.
PubMed 22469966Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.
PubMed 26023551Dib S, Wells JCK, Fewtrell M. A within-subject comparison of different relaxation therapies in eliciting physiological and psychological changes in young women. PeerJ. 2020 May 22;8:e9217. doi: 10.7717/peerj.9217. eCollection 2020.
PubMed 32509467Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.
PubMed 26495909
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT06864455
- Acronym / sponsor ID
- JKEUPM-2024-205
- Conditions
- Behaviour, Psychology, Physiology, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- European Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery Meditation | Experimental | Behavioral: Guided Imagery MeditationParticipants 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. |
| Religious Recitation | Experimental | Behavioral: Religious Recitation-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. |
| Infant Video with Music | Experimental | Behavioral: Infant Video with MusicThe 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 |
| Distraction with News and Media | Experimental | Behavioral: Distraction with News and MediaThe 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. |
| Control | Experimental | Behavioral: ControlNo intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Malaysian women of reproductive age (18-49 years)
- Muslim
- Non-smoker
- Understand English or Malay
- Currently breastfeed their infants
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery MeditationAudio meditation by Sheri Menelli, for 10-14minutes | Behavioural | Guided Imagery Meditation |
| Religious Recitationlisten to Surah Ar-Rahman for 14 minutes | Behavioural | Religious Recitation |
| Infant Video with Music10 minutes of slides show of infant's image and video | Behavioural | Infant Video with Music |
| Distraction with News and Media10 minutes of phone use | Behavioural | Distraction with News and Media |
| ControlAll participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting. | Behavioural | Control |
Primary outcome
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).
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).
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).
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).
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).
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.
3 secondary outcomes
Fat
Time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).
Carbohydrate
Time frame: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
Total energy
Time frame: Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 31889973Yu J, Wells J, Wei Z, Fewtrell M. Effects of relaxation therapy on maternal psychological state, infant growth and gut microbiome: protocol for a randomised controlled trial investigating mother-infant signalling during lactation following late preterm and early term delivery. Int Breastfeed J. 2019 Dec 16;14:50. doi: 10.1186/s13006-019-0246-5. eCollection 2019.
- Background: PubMed 30351172Yu J, Wells J, Wei Z, Fewtrell M. Randomized Trial Comparing the Physiological and Psychological Effects of Different Relaxation Interventions in Chinese Women Breastfeeding Their Healthy Term Infant. Breastfeed Med. 2019 Jan/Feb;14(1):33-38. doi: 10.1089/bfm.2018.0148. Epub 2018 Oct 23.
- Background: PubMed 29105966Mohd Shukri NH, Wells JCK, Fewtrell M. The effectiveness of interventions using relaxation therapy to improve breastfeeding outcomes: A systematic review. Matern Child Nutr. 2018 Apr;14(2):e12563. doi: 10.1111/mcn.12563. Epub 2017 Nov 6.
- Background: PubMed 31161202Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
- Background: PubMed 28900859Rafique R, Anjum A, Raheem SS. Efficacy of Surah Al-Rehman in Managing Depression in Muslim Women. J Relig Health. 2019 Apr;58(2):516-526. doi: 10.1007/s10943-017-0492-z.
- Background: PubMed 34624025Nomkin LG, Gordon I. The relationship between maternal smartphone use, physiological responses, and gaze patterns during breastfeeding and face-to-face interactions with infant. PLoS One. 2021 Oct 8;16(10):e0257956. doi: 10.1371/journal.pone.0257956. eCollection 2021.
- Background: PubMed 22469966Keith DR, Weaver BS, Vogel RL. The effect of music-based listening interventions on the volume, fat content, and caloric content of breast milk-produced by mothers of premature and critically ill infants. Adv Neonatal Care. 2012 Apr;12(2):112-9. doi: 10.1097/ANC.0b013e31824d9842.
- Background: PubMed 26023551Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.
- Background: PubMed 32509467Dib S, Wells JCK, Fewtrell M. A within-subject comparison of different relaxation therapies in eliciting physiological and psychological changes in young women. PeerJ. 2020 May 22;8:e9217. doi: 10.7717/peerj.9217. eCollection 2020.
- Background: PubMed 26495909Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.
- Individual participant dataSharing planned: No. The study results, including aggregated data, will be shared to contribute to broader scientific understanding. However, due to privacy and confidentiality concerns, individual participant data will not be shared. Only de-identified, summary-level data (e.g., group results, statistical analyses) will be made available to the public or other researchers.
Related trials for Behaviour
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery Meditation, Religious Recitation and Infant Video with Music in people with Behaviour and Psychology, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (BPM) (time frame: From enrollment to the end of the 5-session intervention (within 2 weeks).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06864455, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.