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Premature BirthMassageNCT04980053

The Impact of Back and Breast Massage

A study testing massage in people with Premature Birth, run by Seyma Kilci Erciyas at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the study, selections to the experimental and control groups will be made randomly and simple randomization method will be used. In this context, the individuals included in the research will be assigned to the control and initiative groups respectively and randomized by an expert statistician.The sample of the… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Premature Birth
What is being tested?
massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Aug 2021to 10 Jun 2022
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Having a caesarean or vaginal delivery for the first time,
  • Giving preterm birth between 32-37 weeks,
  • Having only one baby,
  • Having a baby with an APGAR score above 4,
  • Having the baby in the intensive care unit or being apart from the baby,
  • Not having any psychiatric disease,
  • Being aged 18 and over and having no communication problems such as seeing, hearing or speaking.

Who cannot join

  • Having a mental and psychological disorder,
  • being HIV-infected
  • Having a breast surgery before, or having a history of breast cancer,
  • Having breast infection,
  • Living apart from the husband or being divorced,
  • Having lost the baby.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Zonguldak Gynecology and Pediatrics Hospital

    Zonguldak, Center

    Mustafa Karadeniz

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Impact of Back and Breast Massage Practised on Mothers With Preterm Birth on the Amount of Milk and Level of Anxiety

In the study, selections to the experimental and control groups will be made randomly and simple randomization method will be used. In this context, the individuals included in the research will be assigned to the control and initiative groups respectively and randomized by an expert statistician.The sample of the study was found to be at the 95% confidence interval and at the level of α= 0.05. The effect size was found to be 0.5703 based on previous studies. With a theoretical power of 0.95, the minimum sample size was totally calculated as 51, 17 for the intervention 1 (back massage), 17 for the intervention 2 (breast massage) group and 17 for the control group. However, it was aimed to reach 60 people by predicting that there might be case losses, and it was planned to recruit 20 people for each group.

The dependent variables of the study are the amount of breast milk and the level of anxiety. The independent variable is the back and breast massage practice.

This research will be carried out in Zonguldak Gynecology and Pediatrics Hospital between 1st July 2021-2022.

Read the detailed description

The data of the research will be collected in two phases. In the first phase, the data will be collected by the researcher by face-to-face interview technique with mothers having just given birth in the hospital and meeting the inclusion criteria of the study. At this phase, "Informed Consent Form" prepared by the researcher in line with the literature, "Personal Information Form", "Breastmilk Evaluation Form" and "State-Trait Anxiety Scale" will be used to collect data.

In addition, a digital thermometer to adjust the room temperature and milk storage bags to store the milk will be used. In the second phase, data will be collected by calling the mothers by phone (audio, video) after they are discharged from the hospital. At this phase, "Post-Discharge Breast Milk Evaluation Form", "State-Trait Anxiety Scale" and "New-born Nutritional Status Evaluation Form" will be used. "Personal Information Form", which will be used in the collection of data consists of 20 questions about the socio-demographic characteristics (age, education level, region of residence until the age of 15, spouse's education level, employment status, occupation, family type, income status), fertility characteristics (number of pregnancies, week of birth, type of birth, the state of oxytocin given at birth, planning status of pregnancy, encountering problems during pregnancy, baby's gender and birth weight, baby's height and head circumference), APGAR score of the baby, the person that make her give birth and mother's body mass index, the status of smoking and medicine or herbal product usage to increase breast milk. Informed consent will be obtained if women meeting the inclusion criteria agree to participate in the research. After obtaining their consent, a pre-test will be applied to the women with the "Personal Information Form" and the "State-Trait Anxiety Scale" by face-to-face interview technique. Both state and trait anxiety scales are of 4-point Likert type. There are 10 reversed statements in the state anxiety scale and 7 reversed statements in the trait anxiety scale. In the state anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. Direct statements express negative emotions, reversed statements express positive emotions. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety. According to Öner, in Spielberg's state and trait anxiety inventory, 0-19 points is evaluated as no anxiety, 20-39 points as mild anxiety, 40-59 points as moderate anxiety, 60-79 points as severe anxiety and 80 points as severe anxiety-panic).

Randomized assignment to the experimental and control groups will be made by a statistician in order to control the randomization and selection bias in the study. Participants will be included in initiative 1 (back massage), initiative 2 (breast massage) or control group according to randomized assignments after pre-test application.

Implementation of the Research in the Control Group No intervention will be made to the control group, standard hospital procedures will be applied and the relevant forms will be filled out. Until the mother is discharged from the hospital, the amount of milk obtained from the mother will be measured by the researcher with the "Breast Milk Evaluation Form", and the breast milk will be measured in the storage bag and delivered to the baby nurses. Covid-19 precautions will be taken in all controls of the mother (hand washing, surgical mask, gloves, apron, face visor). When the mother is discharged from the hospital, the "Post-Discharge Breast Milk Evaluation Form" will be given to the mother and she will be told how to fill it out. The contact numbers of the mothers will be received and information about the measurements filled in the form will be obtained twice a day. Anxiety levels of mothers will be determined with a post-test using the "State-Trait Anxiety Scale", just before their discharge from hospital and on the 5th-7th days. The mothers will be called again at the 6th week of postpartum, and the "New-born Nutritional Status Evaluation Form" will be applied.

Implementation of Research in the Initiative Group The first back massage will be initiated in the first 2 hours after birth and it will be performed every 6 hours for 15 minutes (first 2 hours, 6th, 12th, 18th, 24th, 30th, 36th, 42nd, 48th hour, etc.) until the mother is discharged from the hospital. After the mother's outfits are removed and the mother is situated in a suitable position, the back of the mother will be massaged by euphlorage (stroking), petrissage (pressing the back), friction methods. Then, the mother's breast will be milked by hand and the milk obtained from the breast will be measured in the breast milk storage bag and delivered to the baby nurses. The amount of milk will be measured with the "Breast Milk Evaluation Form".

Before the mother's being discharged from the hospital, a family member will be taught about the fact that how the back massage is practised and asked to practise it at home until the 5th-7th day. The video for the practice of the back massage to be applied at home will be taken by the researcher. Both the video and the brochures will be given to the mother and the person who will apply the massage. Before the mother's being discharged, whether the family member practises the massage correctly or not will be observed. After being discharged, video or audio calls will be made with the family member and asked about whether he/she practices the back massage on the mother and the effectiveness of the massage will be evaluated. The length of the back massage to be practised at home will be for 15 minutes, four times a day (every 6 hours) that is in the morning, at noon, in the evening and at night. Besides this, when the mother is discharged from the hospital, the "Post-Discharge Breast Milk Evaluation Form" will be given to the mother and she will be told how to fill it out. Information about the form will be obtained twice a day by contacting the mother. Anxiety levels will be determined with a post-test using the "State-Trait Anxiety Scale" (Appendix 5) before being discharged and on the 5th-7th days, with. At the 6th week of postpartum, the breastfeeding status of mothers will be evaluated with the "Nutrition Status of the New-born Evaluation Form".

Initiative 2 (breast massage group): The first breast massage will be initiated in the first 2 hours after delivery and it will be practised every 6 hours (first 2 hours, 6th, 12th, 18th, 24th, 30th, 36th, 42nd. , 48th hour) until being discharged. After the researcher washes her hands, the mother's outfits are removed and she is situated in a sitting position, the massage will be practised on both breasts for 10 minutes by the researcher herself. After the breast massage, the mother will be milked by hand and the milk obtained from the mother will be measured in the breast milk storage bag and delivered to the baby nurses. The amount of milk obtained from the mother will be measured with the "Breast Milk Evaluation Form".

The mother will be taught about the breast massage and asked to practise it at home until the 5th-7th day. A video about the self-practice of breast massage will be taken and given to the mother with the brochures. Self-practice of breast massage takes an average of 2-3 minutes and consists of five steps which are pumping the breast, pressing against the rib cage, clockwise or counter-clockwise circular movements, sliding the breast up and down, and back and forth movements. Each step will be performed five times and before each milking time . Whether the mother practices breast massage correctly or not will be evaluated before her being discharged. After being discharged, video or audio calls will be made with the mother and asked about whether she practices the massage herself and the effectiveness of the massage will be evaluated. In addition, while the mother is being discharged from the hospital, the "Post-Discharge Breast Milk Evaluation Form" will be given to the mother and she will be told how to fill it out. Information about the form will be obtained twice a day by contacting the mother. Anxiety levels will be determined with a post-test using the "State-Trait Anxiety Scale", before being discharged and on the 5th-7th days. At the 6th week of postpartum, the breastfeeding status of mothers will be evaluated with the "Nutrition Status of the New-born Evaluation Form".

Conditions
Premature Birth
Being tested
massage
Keywords
breast massage, breast milk, back massage, oxytocın, anxıety
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • massageOther

    Also called back massage, breast massage

    Intervention group Control group

Study groups in NCT04980053
Study groupRoleWhat they receive
Back MassageExperimentalBack massage will be initiated in the first 2 hours after birth and it will be performed every 6 hours for 15 minutes until the mother is discharged from the hospital. After the mother's outfits are removed and the mother is situated in a suitable position, the back of the mother will be massaged by euphlorage, petrissage, friction methods. Then, the participant"s breast will be milked by hand every 3 hours and will be measured in the breast milk storage bag and delivered to the baby nurses until the 5th-7th day.
Receives: Other: massage
Breast MassageExperimentalBreast massage will be initiated in the first 2 hours after delivery and it will be practised every 6 hours until being discharged. After the researcher washes her hands, the participant's outfits are removed and she is situated in a sitting position, the massage will be practised on both breasts for 10 minutes by the researcher herself. After the mother's breast will be milked by hand every 3 hours and the milk obtained from the breast will be measured in the breast milk storage bag and delivered to the baby nurses.
Receives: Other: massage
Control GroupNo interventionNo intervention will be made to the control group, standard hospital procedures will be applied and the relevant forms will be filled out. Until the mother is discharged from the hospital, the amount of milk obtained from the mother will be measured every 3 hours by the researcher.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of Milk

    measured in the breast milk storage bag (ml)

    Measured: Change from Amount of Milk 7 Days

  2. Level of Anxiety

    The trait anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    Measured: 1th day

  3. Level of Anxiety

    The trait anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    Measured: 7th day

  4. Level of Anxiety

    The trait anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    Measured: 6th week

  5. Socio-demographic characteristics of participant

    education level

    Measured: 1th day

  6. Socio-demographic characteristics of participant

    age

    Measured: 1th day

  7. Socio-demographic characteristics of participant

    region of residence until the age of 15

    Measured: 1th day

  8. Socio-demographic characteristics of participant

    spouse's education level,

    Measured: 1th day

  9. Socio-demographic characteristics of participant

    employment status

    Measured: 1th day

  10. Socio-demographic characteristics of participant

    occupation

    Measured: 1th day

  11. Socio-demographic characteristics of participant

    family type

    Measured: 1th day

  12. Socio-demographic characteristics of participant

    income status

    Measured: 1th day

  13. Fertility characteristics of partıcipant

    number of pregnancies

    Measured: 1th day

  14. Fertility characteristics of partıcipant

    week of birth

    Measured: 1th day

  15. Fertility characteristics of partıcipant

    type of birth

    Measured: 1th day

  16. Fertility characteristics of partıcipant

    the state of oxytocin given at birth

    Measured: 1th day

  17. Fertility characteristics of partıcipant

    encountering problems during pregnancy

    Measured: 1th day

  18. Fertility characteristics of partıcipant

    smoking during pregnancy

    Measured: 1th day

  19. Fertility characteristics of partıcipant

    to take medicine or herbal product usage to increase breast milk

    Measured: 1th day

  20. Fertility characteristics of partıcipant

    the person that make her give birth

    Measured: 1th day

  21. Fertility characteristics of partıcipant

    mother's body mass index (kg/m^2)

    Measured: 1th day

  22. Fertility characteristics of partıcipant

    mother's weight (kg)

    Measured: 1th day

  23. Fertility characteristics of partıcipant

    mother's weight (cm)

    Measured: 1th day

  24. Fertility characteristics of partıcipant

    to take vitamin in pregnancy

    Measured: 1th day

  25. Fertility characteristics of partıcipant

    to take iron preparation in pregnancy

    Measured: 1th day

  26. Fertility characteristics of partıcipant

    to take breastfeeding education in pregnancy

    Measured: 1th day

  27. Characteristics of baby

    baby's gender

    Measured: 1th day

  28. Characteristics of baby

    birth weight

    Measured: 1th day

  29. Characteristics of baby

    head circumference

    Measured: 1th day

  30. Characteristics of baby

    APGAR score

    Measured: 1th day

  31. Characteristics of baby

    reason for hospitalization

    Measured: 1th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start6 Aug 2021 (estimated)
  3. Primary completion10 Mar 2022 (estimated)
  4. Study completion10 Jun 2022 (estimated)

Resources

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
Sequential
Model description
20 for intervention 1 (back massage) group, 20 for intervention 2 (breast massage) group and 20 for control group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04980053
Sponsor's protocol ID
Seyma Kilci Erciyas
Acronym
Massage
Status last verified
Aug 2021
First submitted
20 Jun 2021
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Since this is a doctoral thesis, it is planned to be shared after the thesis is published.

Questions about this trial

What is this clinical trial studying?

A study testing massage in people with Premature Birth, run by Seyma Kilci Erciyas 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?

The sponsor lists 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Şeyma K ERCİYAS (5454720162 ext. +09, seymakilcisk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of Milk (time frame: Change from Amount of Milk 7 Days). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Aug 2021.

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