Growth Clinical Trial
Official title:
The Effect of Infant Massage on Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence
Verified date | June 2022 |
Source | Bandirma Onyedi Eylül University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Touch is an essential element in the healthy growth and development of the baby. Infant massage is the best way to touch babies. In line with the literature review on the subject, it has been reported that infant massage supports growth and development in infants, improves attachment between mothers and babies and decreases the level of depression and anxiety in mothers. With the coronavirus pandemic, quarantine decisions have been implemented all over the world. In addition to the stress brought on by their new roles, new mothers have to cope with the anxiety and stress of being a parent and babysitting during the pandemic period. During the pandemic process, it is seen that depression and anxiety levels increase in mothers who have given birth, and maternal attachment is negatively affected. Depression and anxiety in mothers negatively affect the cognitive, physical, social and emotional development of babies. It is very important to encourage practices that increase mother-infant interaction, such as infant massage, during the pandemic period. The universe of the research will consist of mothers and their babies who were followed up in İzmir Karşıyaka No. 8 Gülay Kaymak Family Health Center and Karşıyaka No. 4 Bostanlı-2 Family Health Center between May 2021 and May 2022. The sample of the study is 38-42. It is planned to create babies born in the 4th week of pregnancy, with a birth weight of over 2500 grams and who have completed their fourth week (one month old) (n:60).
Status | Completed |
Enrollment | 60 |
Est. completion date | June 17, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Weeks |
Eligibility | Inclusion Criteria: - The mother knows how to read, write and use a computer, - The mother's consent to participate in the study, - Babies 38-42. to be born at the gestational week and to have a birth weight of over 2500 grams and to have completed the fourth week. Exclusion Criteria: - Multiple pregnancy - The mother has a disease or disability that prevents her from massaging her baby. |
Country | Name | City | State |
---|---|---|---|
Turkey | Karsiyaka 4 No'lu Bostanli- 2 Aile Sagligi Merkezi | Izmir | Karsiyaka |
Turkey | Karsiyaka 8 Nolu Gülay Kaymak Aile Sagligi Merkezi | Izmir | Karsiyaka |
Lead Sponsor | Collaborator |
---|---|
Bandirma Onyedi Eylül University |
Turkey,
Gürol A, Polat S. The Effects of Baby Massage on Attachment between Mother and their Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Mar;6(1):35-41. doi: 10.1016/j.anr.2012.02.006. Epub 2012 Mar 10. — View Citation
Lu LC, Lan SH, Hsieh YP, Lin LY, Chen JC, Lan SJ. Massage therapy for weight gain in preterm neonates: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2020 May;39:101168. doi: 10.1016/j.ctcp.2020.101168. — View Citation
Vicente S, Veríssimo M, Diniz E. Infant massage improves attitudes toward childbearing, maternal satisfaction and pleasure in parenting. Infant Behav Dev. 2017 Nov;49:114-119. doi: 10.1016/j.infbeh.2017.08.006. Epub 2017 Sep 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal Attachment Inventory (MAI) | The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (pre-intervention assessment) | end of week 4 | |
Primary | Maternal Attachment Inventory (MAI) | The MAI is a 26-item self-report questionnaire used to measure mother-child attachment. Each item represents a maternal activity (e.g. 'I tell others about my baby') or feeling (e.g. 'I feel love for my child') which indicates affection towards the child. Items are scored on a 4-point Likert scale ranging from 1 (almost never)-4 (almost always). Total MAI scores range from 26-104, with higher scores indicating greater maternal attachment. The mean score of mother attachment inventory (post-intervention assessment) | end of week 20 | |
Primary | Growth Parameter | The mean of baseline weight (in grams) | end of week 4 | |
Primary | Growth Parameter | The mean change in body weight from end of week 4 to end of week 8 (in grams) | end of week 8 | |
Primary | Growth Parameter | The mean change in body weight from end of week 8 to end of week 12 (in grams) | end of week 12 | |
Primary | Growth Parameter | The mean change in body weight from end of week 12 to week end of 16 (in grams) | end of week 16 | |
Primary | Growth Parameter | The mean change in body weight from end of week 16 to week end of 20 (in grams) | end of week 20 | |
Primary | Growth Parameter | The mean of baseline body length (in centimeters) | end of week 4 | |
Primary | Growth Parameter | The mean change in body length from end of week 4 to end of week 8 (in centimeters) | end of week 8 | |
Primary | Growth Parameter | The mean change in body length from end of week 8 to end of week 12 (in centimeters) | end of week 12 | |
Primary | Growth Parameter | The mean change in body length from end of week 12 to end of week 16 (in centimeters) | end of week 16 | |
Primary | Growth Parameter | The mean change in body length from end of week 16 to end of week 20 (in centimeters) | end of week 20 | |
Primary | Head circumference | The mean of baseline head circumference (in centimeters) | end of week 4 | |
Primary | Head circumference | The mean change in head circumference from end of week 4 to end of week 8 (in centimeters) | end of week 8 | |
Primary | Head circumference | The mean change in head circumference from end of week 8 to end of week 12 (in centimeters) | end of week 12 | |
Primary | Head circumference | The mean change in head circumference from end of week 12 to end of week 16 (in centimeters) | end of week 16 | |
Primary | Head circumference | The mean change in head circumference from end of week 16 to end of week 20 (in centimeters) | end of week 20 | |
Secondary | Pharis Self-Confidence | The Pharis Self-Confidence Scale, which is a 13-item five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 to 5 (not at all, very little, moderately, very much, completely). The increase in the total score obtained from the scale indicates that the self-confidence levels of the mothers increase in baby care. The lowest score on the "Pharis Self-Confidence" scale is 13, the highest score is 65.The mean score of pharis self-confidence (pre-intervention assessment) | end of week 4 | |
Secondary | Pharis Self-Confidence | The Pharis Self-Confidence Scale, which is a 13-item five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 to 5 (not at all, very little, moderately, very much, completely). The increase in the total score obtained from the scale indicates that the self-confidence levels of the mothers increase in baby care. The lowest score on the "Pharis Self-Confidence" scale is 13, the highest score is 65.The mean score of pharis self-confidence (pre-intervention assessment) | end of week 20 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05551975 -
Preterm Infants Fed a Human Milk Fortifier
|
N/A | |
Completed |
NCT01162798 -
Preterm Infant Growth
|
N/A | |
Completed |
NCT01721512 -
The Growth and Development of Breast and Formula Fed Term Asian Infants
|
N/A | |
Active, not recruiting |
NCT00970398 -
Effect of an Infant Formula on Infant Growth, Health and Immune Functions
|
N/A | |
Completed |
NCT01666457 -
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
|
||
Completed |
NCT00808756 -
Study on Fermentable Carbohydrates in Healthy Infants
|
N/A | |
Completed |
NCT00997971 -
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
|
Phase 3 | |
Completed |
NCT03276663 -
Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula
|
N/A | |
Recruiting |
NCT02695784 -
Probiotics After Discharge
|
Phase 4 | |
Withdrawn |
NCT02860026 -
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
|
N/A | |
Completed |
NCT01128517 -
Maternal Education on Complementary Feeding and Infant Outcome
|
N/A | |
Completed |
NCT00282113 -
Effects of Probiotic and Prebiotic Combinations on Premature Infants
|
N/A | |
Completed |
NCT03276884 -
Growth and Tolerance of Young Infants
|
N/A | |
Completed |
NCT04055363 -
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
|
N/A | |
Not yet recruiting |
NCT05616117 -
Next-generation Effects of Vitamin D Supplementation in Pregnancy
|
||
Active, not recruiting |
NCT02410057 -
Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula
|
N/A | |
Completed |
NCT01210391 -
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
|
N/A | |
Completed |
NCT01158352 -
Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children
|
N/A | |
Completed |
NCT01109849 -
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
|
Phase 4 | |
Completed |
NCT00705445 -
Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan
|
Phase 2/Phase 3 |