Colic, InfantilerandomizedNCT06727760
The Effect of Colic Massage and Kangaroo Care on Babies and Their Mothers
A study testing massage and kangroo care in people with Colic, Infantile and Crying Time in Colicky Infants, run by Gulsah Sunay Ertem at 1 site in Turkey (Türkiye).
Trial summary
Background: Infantile colic is a condition characterized by inconsolable crying in infants under three months of age. Purpose: The aim of this study is to determine the effects of colic massage and kangaroo care on infantile colic symptoms, crying, and sleep duration. Read more about this study
- Who is it for?
- Ages 3 to 8 weeks
- Conditions the study is for
- Colic, Infantile, Crying Time in Colicky Infants, Postpartum Depression
- What is being tested?
- massage and kangroo care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2022to 22 Feb 2023
- 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 3 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Baby's Inclusion Criteria:
- Diagnosed with infantile colic
- Being born at term
Baby's Exclusion Criteria:
- Lactose allergy,
- Diagnosed with another chronic disease
- Skin problem,
- Weighing less than 2500 grams
- Having congenital anomalies
- Vomiting, constipation and malnutrition
Mothers' inclusion criteria
- being a volunteer
- being literate and
- having a smart phone.
Mothers' exclusion criteria
- using incorrect massage and kangaroo care
- using other traditional and medical treatments during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk City Hospital
Balıkesir, Altıeylül, 10020
About this study
Official title: Investigation of the Effects of Colic Massage and Kangaroo Care on Colicky Infants and Their Mothers
Background: Infantile colic is a condition characterized by inconsolable crying in infants under three months of age.
Purpose: The aim of this study is to determine the effects of colic massage and kangaroo care on infantile colic symptoms, crying, and sleep duration.
Method: Our study was conducted at the Child Health and Diseases Polyclinic of Atatürk city Hospital between March 2022 and April 2023. The study sample consisted of infants diagnosed with infantile colic who applied to the polyclinic and their mothers. 96 infants were randomly selected in our study using the randomization method. They were assigned to the massage, kangaroo care, and control groups. Infants in the colic massage and kangaroo care groups received interventions for 15-20 minutes in the morning and evening, while the control group received no intervention. Before the intervention, crying and sleep duration were monitored and recorded for 24 hours for one week in all three groups. Mothers continued the massage and kangaroo care application for 3 weeks. In the 3rd week of the application, 24-hour crying and sleep duration were recorded again for one week. Before and after the interventions, the Infantile Colic Scale (ICS) was applied to all three groups. The three groups were compared with the Wilcoxon test.
Read the detailed description
Data were collected from volunteer mothers of babies diagnosed with infantile colic who applied to the Child Health and Diseases outpatient clinic between March 2022 and February 2023 and who met the inclusion criteria for the study. The mothers were informed about the research through the "Informed Consent Form". Data were collected by the researcher through face-to-face interviews. The "Mother-Baby Information Form", "Infant Colic Scale", "Postpartum Specific Anxiety Scale", "Barkin Maternal Function Scale" and "Beck Depression Scale" were applied to the mothers in the massage, kangaroo care and control groups in the outpatient clinic before the intervention. They were then given the "Crying and Sleep Duration Form" and asked to fill it out at home for a week. Mothers who filled out the crying and sleep duration forms for a week were given an appointment for a home visit. The homes of these mothers were visited and the crying and sleep duration forms filled out for a week were collected. After collection, mothers were taught infantile colic massage and kangaroo care on a baby manikin according to randomization and were allowed to practice (The researcher has a "holistic infant massage certificate"). Mothers in the massage group applied colic massage according to the "Educational Colic Massage Checklist" for 15-20 minutes twice a day for three weeks when the baby was calm and during colic attacks. Mothers in the kangaroo care group applied kangaroo care according to the "Educational Kangaroo Care Checklist" for 15-20 minutes twice a day for three weeks when the baby was calm and during colic attacks. No intervention was made to the mothers in the control group. Mothers in all three groups filled out the "Crying and Sleep Duration Form" again for one week in the last week of the study. At the end of the study, the "Infantile Colic Scale", "Postpartum Specific Anxiety Scale", "Barkin Maternal Function Scale" and "Beck Depression Scale" were applied to the mothers in all three groups again (Mothers were supported with video calls and video recordings during the first massage and kangaroo care application and when needed). The study lasted four weeks in total and the intervention lasted three weeks.
- Conditions
- Colic, Infantile, Crying Time in Colicky Infants, Postpartum Depression, Postpartum Anxiety, Motherhood
- Being tested
- massage, kangroo care
- Keywords
- colic, cangroo care, crying and sleeping duration, nursing education, postpartum anxiety, postpartum depression
- Medical subject headings
- Colic, Depression, Postpartum, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageBehavioural
The mothers in the massage group applied colic massage according to the "Educational Colic Massage Checklist" twice a day for 15-20 minutes each time for three weeks, when the baby was calm and during colic attacks.
kangroo careBehavioural
The mothers in the kangaroo care group applied kangaroo care according to the "Educational Kangaroo Care Checklist" twice a day for three weeks for 15-20 minutes each time when the baby was calm and during colic attacks.
| Study group | Role | What they receive |
|---|---|---|
| massage group | Experimental | Colic massage is applied to babies with infantile colic Receives: Behavioral: massage |
| kangaroo care group | Experimental | Kangaroo care is applied to babies with infantile colic Receives: Behavioral: kangroo care |
| control group | No intervention | No intervention is applied to babies with infantile colic |
What is being measured
The primary outcome is the main question the study is designed to answer.
infantile scale scores
The Infantile Colic Scale consists of 19 questions. The scale has 5 subscales: Cow's Milk/Soy Protein Allergy/Intolerance, Immature Gastrointestinal System, Immature Central Nervous System, Difficult Infant Temperament, Parent-Infant Interaction, and Problematic Infant. Scale items are rated on a Likert-type scale ranging from 1 to 6. Ratings range from 1 (strongly disagree) to 6 (strongly agree). Negative questions were reverse-coded for interpreting the scores. Item 3 in the immature gastrointestinal system subscale, items 7, 8, and 9 in the immature central nervous system subscale, items 13, 14, and 15 in the difficult infant temperament subscale, and items 17 and 19 in the parent-infant interaction and problematic infant subscales were reverse-coded.Data are expressed as mean ± SD and median (minimum: maximum).
Measured: up to 3 weeks
mothers' postpartum anxiety scores
The Postpartum Specific Anxiety Inventory consists of 51 items. Responses to the items are rated on a 4-point Likert scale ranging from 1 to 4 (1=never, 2=sometimes, 3=usually, 4=always). The total score for the level of postpartum anxiety is; below 73 points is considered low risk, between 74 and 100 points is considered moderate risk, and above 101 points is considered high risk. The lowest possible score is 51, and the highest score is 204. 8 The scale has four subscales: Items 1-15 assess maternal adequacy and attachment concerns, items 16-26 assess infant safety and well-being concerns, items 27-33 assess practical infant care concerns, and items 34-51 assess psychosocial adjustment to motherhood.
Measured: up to 3 weeks
mother's depression scores
The scale consists of 21 items related to depressive symptoms such as pessimism, sense of failure, dissatisfaction, guilt, restlessness, fatigue, decreased appetite, indecisiveness, sleep disorders, and social withdrawal. The total score that can be obtained from the scale varies between 0-63. Those who scored 17 and above were accepted as 'depressive symptoms' as 10. The Turkish validity and reliability studies of the BDI were conducted by Teğin in 1980 and by Hisli in 1989, and the Cronbach alpha value was found to be 0.80. The BDI scoring for the severity of depression is interpreted as 0-9 = Minimal, 10-16 = Mild, 17-29 = Moderate, 30-63 = severe, depression. It takes approximately 15 minutes to complete the scale. However, this time may vary depending on the patient's level of education and whether or not they have obsessive characteristics.
Measured: up to 3 weeks
Secondary outcomes (2)
maternal function scores.
The scale's self-care dimension was calculated as 0.66, maternal psychology sub-dimension as 0.71, baby care sub-dimension as 0.62, social support sub-dimension as 0.69, and adaptation to motherhood sub-dimension as 0.50. The responses on the scale are numbered from 0 to 6. 0 is expressed as "completely disagree", 1 as "disagree", 2 as "somewhat disagree", 3 as "undecided", 4 as "somewhat agree", 5 as "agree", and 6 as "completely agree". The lowest score that can be obtained in the scoring of the scale is 0, and the highest score is 96. It is accepted that the functional status increases as the scores increase. BAFÖ is applied to mothers with babies younger than 18 months.
Measured: up to 3 weeks
colic babies crying and sleeping time
It is a form created by the researcher in which infants' daily crying and sleep durations can be recorded at every hour of the day and on every day of the week.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start8 Mar 2022
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Colic, InfantileStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsah Sunay Ertem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulsah Sunay Ertem, Uludag University
- Investigators
- nurcan özyazıcıoğlu, professor, Study director, bursa uludağ üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727760
- Sponsor's protocol ID
- E-25691463-900-35292
- Acronym
- randomized
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Higgins M, St James Roberts I, Glover V. Postnatal depression and mother and infant outcomes after infant massage. J Affect Disord. 2008 Jul;109(1-2):189-92. doi: 10.1016/j.jad.2007.10.027. Epub 2007 Dec 20.
PubMed 18086500Onozawa K, Glover V, Adams D, Modi N, Kumar RC. Infant massage improves mother-infant interaction for mothers with postnatal depression. J Affect Disord. 2001 Mar;63(1-3):201-7. doi: 10.1016/s0165-0327(00)00198-1.
PubMed 11246096Lotfalipour B, Tirgari B, Pouraboli B, Mirzaee M. Effect of Preterm Infant Massage by the Mother on the Mood of Mothers Having Preterm Infants. J Chiropr Med. 2019 Mar;18(1):67-76. doi: 10.1016/j.jcm.2018.11.001. Epub 2019 May 7. French.
PubMed 31193199Lonstein JS. Regulation of anxiety during the postpartum period. Front Neuroendocrinol. 2007 Aug-Sep;28(2-3):115-41. doi: 10.1016/j.yfrne.2007.05.002. Epub 2007 Jun 2.
PubMed 17604088Lee SB, Shin HS. [Effects of Kangaroo Care on anxiety, maternal role confidence, and maternal infant attachment of mothers who delivered preterm infants]. Taehan Kanho Hakhoe Chi. 2007 Oct;37(6):949-56. doi: 10.4040/jkan.2007.37.6.949. Korean.
PubMed 17992067Fujita M, Endoh Y, Saimon N, Yamaguchi S. Effect of massaging babies on mothers: pilot study on the changes in mood states and salivary cortisol level. Complement Ther Clin Pract. 2006 Aug;12(3):181-5. doi: 10.1016/j.ctcp.2006.01.003. Epub 2006 Mar 13.
PubMed 16835028Feijo L, Hernandez-Reif M, Field T, Burns W, Valley-Gray S, Simco E. Mothers' depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Dev. 2006 Jul;29(3):476-80. doi: 10.1016/j.infbeh.2006.02.003. Epub 2006 Mar 27.
PubMed 17138300Erduran B, Yaman Sozbir S. Effects of intermittent kangaroo care on maternal attachment, postpartum depression of mothers with preterm infants. J Reprod Infant Psychol. 2023 Nov;41(5):556-565. doi: 10.1080/02646838.2022.2035703. Epub 2022 Feb 7.
PubMed 35129000Badiee Z, Faramarzi S, MiriZadeh T. The effect of kangaroo mother care on mental health of mothers with low birth weight infants. Adv Biomed Res. 2014 Oct 20;3:214. doi: 10.4103/2277-9175.143262. eCollection 2014.
PubMed 25371871Anwar F, Warsi A, Ahmed J, Zaidi B, Turab A, Khan MA, Khan KS. The effectiveness of kangaroo mother care in lowering postpartum depression in mothers of preterm and low birth weight babies: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Apr 12;85(6):2841-2848. doi: 10.1097/MS9.0000000000000480. eCollection 2023 Jun.
PubMed 37941566Parsa P, Karimi S, Basiri B, Roshanaei G. The effect of kangaroo mother care on physiological parameters of premature infants in Hamadan City, Iran. Pan Afr Med J. 2018 May 31;30:89. doi: 10.11604/pamj.2018.30.89.14428. eCollection 2018.
PubMed 30344873Johnson JD, Cocker K, Chang E. Infantile Colic: Recognition and Treatment. Am Fam Physician. 2015 Oct 1;92(7):577-82.
PubMed 26447441Daelemans S, Peeters L, Hauser B, Vandenplas Y. Recent advances in understanding and managing infantile colic. F1000Res. 2018 Sep 7;7:F1000 Faculty Rev-1426. doi: 10.12688/f1000research.14940.1. eCollection 2018.
PubMed 30271572WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.
PubMed 13214956Zeevenhooven J, Koppen IJ, Benninga MA. The New Rome IV Criteria for Functional Gastrointestinal Disorders in Infants and Toddlers. Pediatr Gastroenterol Hepatol Nutr. 2017 Mar;20(1):1-13. doi: 10.5223/pghn.2017.20.1.1. Epub 2017 Mar 27.
PubMed 28401050
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Colic Massage and Kangaroo Care on Colicky Infants and Their Mothers
- ClinicalTrials.gov ID
- NCT06727760
- Acronym / sponsor ID
- randomized / E-25691463-900-35292
- Conditions
- Colic, Infantile, Crying Time in Colicky Infants, Postpartum Depression, Postpartum Anxiety, Motherhood
- Keywords
- colic, cangroo care, crying and sleeping duration, nursing education, postpartum anxiety, postpartum depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gulsah Sunay ErtemUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 11 Dec 2024 (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.
Background: Infantile colic is a condition characterized by inconsolable crying in infants under three months of age.
Purpose: The aim of this study is to determine the effects of colic massage and kangaroo care on infantile colic symptoms, crying, and sleep duration.
Method: Our study was conducted at the Child Health and Diseases Polyclinic of Atatürk city Hospital between March 2022 and April 2023. The study sample consisted of infants diagnosed with infantile colic who applied to the polyclinic and their mothers. 96 infants were randomly selected in our study using the randomization method. They were assigned to the massage, kangaroo care, and control groups. Infants in the colic massage and kangaroo care groups received interventions for 15-20 minutes in the morning and evening, while the control group received no intervention. Before the intervention, crying and sleep duration were monitored and recorded for 24 hours for one week in all three groups. Mothers continued the massage and kangaroo care application for 3 weeks. In the 3rd week of the application, 24-hour crying and sleep duration were recorded again for one week. Before and after the interventions, the Infantile Colic Scale (ICS) was applied to all three groups. The three groups were compared with the Wilcoxon test.
Detailed description
Data were collected from volunteer mothers of babies diagnosed with infantile colic who applied to the Child Health and Diseases outpatient clinic between March 2022 and February 2023 and who met the inclusion criteria for the study. The mothers were informed about the research through the "Informed Consent Form". Data were collected by the researcher through face-to-face interviews. The "Mother-Baby Information Form", "Infant Colic Scale", "Postpartum Specific Anxiety Scale", "Barkin Maternal Function Scale" and "Beck Depression Scale" were applied to the mothers in the massage, kangaroo care and control groups in the outpatient clinic before the intervention. They were then given the "Crying and Sleep Duration Form" and asked to fill it out at home for a week. Mothers who filled out the crying and sleep duration forms for a week were given an appointment for a home visit. The homes of these mothers were visited and the crying and sleep duration forms filled out for a week were collected. After collection, mothers were taught infantile colic massage and kangaroo care on a baby manikin according to randomization and were allowed to practice (The researcher has a "holistic infant massage certificate"). Mothers in the massage group applied colic massage according to the "Educational Colic Massage Checklist" for 15-20 minutes twice a day for three weeks when the baby was calm and during colic attacks. Mothers in the kangaroo care group applied kangaroo care according to the "Educational Kangaroo Care Checklist" for 15-20 minutes twice a day for three weeks when the baby was calm and during colic attacks. No intervention was made to the mothers in the control group. Mothers in all three groups filled out the "Crying and Sleep Duration Form" again for one week in the last week of the study. At the end of the study, the "Infantile Colic Scale", "Postpartum Specific Anxiety Scale", "Barkin Maternal Function Scale" and "Beck Depression Scale" were applied to the mothers in all three groups again (Mothers were supported with video calls and video recordings during the first massage and kangaroo care application and when needed). The study lasted four weeks in total and the intervention lasted three weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| massage group | Experimental | Behavioral: massageColic massage is applied to babies with infantile colic |
| kangaroo care group | Experimental | Behavioral: kangroo careKangaroo care is applied to babies with infantile colic |
| control group | No intervention | –No intervention is applied to babies with infantile colic |
Who may qualify
- Ages
- 3 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| massageThe mothers in the massage group applied colic massage according to the "Educational Colic Massage Checklist" twice a day for 15-20 minutes each time for three weeks, when the baby was calm and during colic attacks. | Behavioural | massage group |
| kangroo careThe mothers in the kangaroo care group applied kangaroo care according to the "Educational Kangaroo Care Checklist" twice a day for three weeks for 15-20 minutes each time when the baby was calm and during colic attacks. | Behavioural | kangaroo care group |
Primary outcome
infantile scale scores
Time frame: up to 3 weeks
The Infantile Colic Scale consists of 19 questions. The scale has 5 subscales: Cow's Milk/Soy Protein Allergy/Intolerance, Immature Gastrointestinal System, Immature Central Nervous System, Difficult Infant Temperament, Parent-Infant Interaction, and Problematic Infant. Scale items are rated on a Likert-type scale ranging from 1 to 6. Ratings range from 1 (strongly disagree) to 6 (strongly agree). Negative questions were reverse-coded for interpreting the scores. Item 3 in the immature gastrointestinal system subscale, items 7, 8, and 9 in the immature central nervous system subscale, items 13, 14, and 15 in the difficult infant temperament subscale, and items 17 and 19 in the parent-infant interaction and problematic infant subscales were reverse-coded.Data are expressed as mean ± SD and median (minimum: maximum).
mothers' postpartum anxiety scores
Time frame: up to 3 weeks
The Postpartum Specific Anxiety Inventory consists of 51 items. Responses to the items are rated on a 4-point Likert scale ranging from 1 to 4 (1=never, 2=sometimes, 3=usually, 4=always). The total score for the level of postpartum anxiety is; below 73 points is considered low risk, between 74 and 100 points is considered moderate risk, and above 101 points is considered high risk. The lowest possible score is 51, and the highest score is 204. 8 The scale has four subscales: Items 1-15 assess maternal adequacy and attachment concerns, items 16-26 assess infant safety and well-being concerns, items 27-33 assess practical infant care concerns, and items 34-51 assess psychosocial adjustment to motherhood.
mother's depression scores
Time frame: up to 3 weeks
The scale consists of 21 items related to depressive symptoms such as pessimism, sense of failure, dissatisfaction, guilt, restlessness, fatigue, decreased appetite, indecisiveness, sleep disorders, and social withdrawal. The total score that can be obtained from the scale varies between 0-63. Those who scored 17 and above were accepted as 'depressive symptoms' as 10. The Turkish validity and reliability studies of the BDI were conducted by Teğin in 1980 and by Hisli in 1989, and the Cronbach alpha value was found to be 0.80. The BDI scoring for the severity of depression is interpreted as 0-9 = Minimal, 10-16 = Mild, 17-29 = Moderate, 30-63 = severe, depression. It takes approximately 15 minutes to complete the scale. However, this time may vary depending on the patient's level of education and whether or not they have obsessive characteristics.
2 secondary outcomes
maternal function scores.
Time frame: up to 3 weeks
colic babies crying and sleeping time
Time frame: up to 3 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 11 Dec 2024.
- Background: PubMed 18086500O'Higgins M, St James Roberts I, Glover V. Postnatal depression and mother and infant outcomes after infant massage. J Affect Disord. 2008 Jul;109(1-2):189-92. doi: 10.1016/j.jad.2007.10.027. Epub 2007 Dec 20.
- Background: PubMed 11246096Onozawa K, Glover V, Adams D, Modi N, Kumar RC. Infant massage improves mother-infant interaction for mothers with postnatal depression. J Affect Disord. 2001 Mar;63(1-3):201-7. doi: 10.1016/s0165-0327(00)00198-1.
- Background: PubMed 31193199Lotfalipour B, Tirgari B, Pouraboli B, Mirzaee M. Effect of Preterm Infant Massage by the Mother on the Mood of Mothers Having Preterm Infants. J Chiropr Med. 2019 Mar;18(1):67-76. doi: 10.1016/j.jcm.2018.11.001. Epub 2019 May 7. French.
- Background: PubMed 17604088Lonstein JS. Regulation of anxiety during the postpartum period. Front Neuroendocrinol. 2007 Aug-Sep;28(2-3):115-41. doi: 10.1016/j.yfrne.2007.05.002. Epub 2007 Jun 2.
- Background: PubMed 17992067Lee SB, Shin HS. [Effects of Kangaroo Care on anxiety, maternal role confidence, and maternal infant attachment of mothers who delivered preterm infants]. Taehan Kanho Hakhoe Chi. 2007 Oct;37(6):949-56. doi: 10.4040/jkan.2007.37.6.949. Korean.
- Background: PubMed 16835028Fujita M, Endoh Y, Saimon N, Yamaguchi S. Effect of massaging babies on mothers: pilot study on the changes in mood states and salivary cortisol level. Complement Ther Clin Pract. 2006 Aug;12(3):181-5. doi: 10.1016/j.ctcp.2006.01.003. Epub 2006 Mar 13.
- Background: PubMed 17138300Feijo L, Hernandez-Reif M, Field T, Burns W, Valley-Gray S, Simco E. Mothers' depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Dev. 2006 Jul;29(3):476-80. doi: 10.1016/j.infbeh.2006.02.003. Epub 2006 Mar 27.
- Background: PubMed 35129000Erduran B, Yaman Sozbir S. Effects of intermittent kangaroo care on maternal attachment, postpartum depression of mothers with preterm infants. J Reprod Infant Psychol. 2023 Nov;41(5):556-565. doi: 10.1080/02646838.2022.2035703. Epub 2022 Feb 7.
- Background: PubMed 25371871Badiee Z, Faramarzi S, MiriZadeh T. The effect of kangaroo mother care on mental health of mothers with low birth weight infants. Adv Biomed Res. 2014 Oct 20;3:214. doi: 10.4103/2277-9175.143262. eCollection 2014.
- Background: PubMed 37941566Anwar F, Warsi A, Ahmed J, Zaidi B, Turab A, Khan MA, Khan KS. The effectiveness of kangaroo mother care in lowering postpartum depression in mothers of preterm and low birth weight babies: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Apr 12;85(6):2841-2848. doi: 10.1097/MS9.0000000000000480. eCollection 2023 Jun.
- Background: PubMed 30344873Parsa P, Karimi S, Basiri B, Roshanaei G. The effect of kangaroo mother care on physiological parameters of premature infants in Hamadan City, Iran. Pan Afr Med J. 2018 May 31;30:89. doi: 10.11604/pamj.2018.30.89.14428. eCollection 2018.
- Background: PubMed 26447441Johnson JD, Cocker K, Chang E. Infantile Colic: Recognition and Treatment. Am Fam Physician. 2015 Oct 1;92(7):577-82.
- Meta-analysis the effect of baby massage in increasing quality of sleep and infant body weight.Link provided by the sponsor.
- The Effects of Kangaroo Mother Care (KMC) on the Fuss and Crying Time of Colicky Infants. Iranian Journal of Neonatology, 6(1).Link provided by the sponsor.
- Effects of abdominal massage on feeding tolerance in preterm infants hospitalized in selected hospitals of Isfahan-Iran.Link provided by the sponsor.
- Kangaroo Mother Care and Neonatal Outcomes in the Pediatric Department of CHU Gabriel ToureLink provided by the sponsor.
- Akdoğan R. The Effect of Spa and Massage Applied to Babies on Colic Symptoms: A Randomized Controlled Trial. PhD Thesis. Istanbul University. Istanbul. 2023Link provided by the sponsor.
- Meta-analysis the effect of baby massage in increasing quality of sleep and infant body weightLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
nurcan özyazıcıoğlu, professor study director
bursa uludağ üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage and kangroo care in people with Colic, Infantile and Crying Time in Colicky Infants, run by Gulsah Sunay Ertem at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Dec 2024. 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 Turkey (Türkiye). 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?
infantile scale scores (time frame: up to 3 weeks). The study lists 3 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 NCT06727760, which also lists 21 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 11 Dec 2024.