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Cesarean SectionNCT06162156

Effects of Back Massage After Cesarean Section

A study testing Back massage in people with Cesarean Section, run by Ordu University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study is to examine the effect of back massage application after cesarean section on women's pain, anxiety, sleep, breastfeeding, comfort, uterine involution process and physiological parameters. This research is a randomized controlled experimental type study with a pretest-posttest control group. Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Section
What is being tested?
Back massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2023to 31 May 2024
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 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Mothers who gave birth at the age of 18 and over
  • The one who is married
  • At least primary school graduate
  • Giving by cesarean section
  • Those who had a cesarean section with regional anesthesia
  • Having a single, healthy newborn at full term
Show all 11Show fewer
  • Those who did not experience any problems during pregnancy
  • Pain intensity is 40 mm or more according to the Visual Analogue Scale
  • Does not react negatively to any attempt at touch, such as massage
  • The tissue integrity in the area to be massaged is complete and healthy
  • Women who agree to participate in the research will be included in the study

Who cannot join

  • Those who gave birth by cesarean section before the 37th week of pregnancy
  • Having diseases such as heart disease, diabetes, hypertension
  • Receiving controlled analgesia after cesarean section
  • Having received a psychiatric diagnosis such as anxiety and depression
  • Those who develop postpartum complications
  • Women who want to leave the research at any stage of the research will be excluded from the research

Trial locations and contacts

1 site in 1 country.

Esra GÜLER EG PhD student contact

0545 628 25 12

esraguleravza0@gmail.com

Nülüfer ERBİL NE Prof. Dr. contact

0535 830 63 57

nulufererbil@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Fatsa State Hospital

    Fatsa, Ordu, 52400

    Esra EG Güler, 4, 0545 628 25 12, esraguleravza0@gmail.com

    Esra EG GÜLER, 1

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Back Massage After Cesarean on Pain, Anxiety, Sleep, Breastfeeding, Comfort, Uterine Involution and Physiological Parameters

The aim of this study is to examine the effect of back massage application after cesarean section on women's pain, anxiety, sleep, breastfeeding, comfort, uterine involution process and physiological parameters. This research is a randomized controlled experimental type study with a pretest-posttest control group. In the research, after obtaining the necessary permissions and the ethics committee report, the application will be carried out to women who have given birth by cesarean section at the State Hospital and meet the criteria for inclusion in the study. Personal Information Form, Richard Campbell Sleep Scale, Trait-Trait Anxiety Inventory, Postpartum Comfort Scale, Bristol Breastfeeding Evaluation Tool, Visual Analog Scale for Pain, Uterine Involution Evaluation Form, Physiological Parameter Form will be used in the research.

Read the detailed description

The aim of this study is to examine the effect of back massage after cesarean section on women's pain, anxiety, sleep, breastfeeding, comfort, uterine involution process and physiological parameters. This research is a randomized controlled experimental type study with a pretest-posttest control group. Personal Information Form, Richard Campbell Sleep Scale, Trait-Trait Anxiety Inventory, Postpartum Comfort Scale, Bristol Breastfeeding Evaluation Tool, Visual Analog Scale for Pain, Uterine Involution Evaluation Form, Physiological Parameter Form will be used in the research.

Collection of Data This research is a randomized controlled experimental type study with a pretest-posttest control group. The data of the research will be collected after the necessary institutional permission and ethics committee approval have been obtained. Data will be collected in three stages. Women who meet the inclusion criteria for the study will be informed about the method to be followed in the research. Those who want to participate in the research will read and sign the volunteer information form.

First Stage:

Women who apply to the selected hospital, meet the inclusion criteria and agree to participate in the study will be visited 12 hours after cesarean delivery, the women will be informed, verbal and written consent will be obtained from women who want to participate in the study, and pre-test data will be collected by the researcher. Before randomization to the intervention and control groups, the researcher will give general information to the mothers about the research at the 12th hour after cesarean section and their written informed consent will be obtained. The pre-test data of the research were collected face to face in an average of 20 minutes with the 'Personal Information Form', 'Trait-Trait Anxiety Inventory', 'Postpartum Comfort Scale', 'Bristol Breastfeeding Evaluation Tool', 'Uterus Involution Evaluation Form' and 'Physiological Parameter Form'. It will be filled in by the participants themselves using the interview technique. The height of the fundus section of the uterus, heart rate, body temperature, oxygen saturation, respiratory rate and blood pressure physiological parameters will be monitored by the researcher.

Second Stage:

'Visual Analog Scala' and 'Physiological Parameter Form' data will be filled in again by the researcher one hour after massage for the intervention group (13 hours after cesarean delivery), and for the control group 13 hours after cesarean delivery.

Third Stage:

Post-test data 24 hours after the intervention group was massaged by the researcher; 'Richard Campbell Sleep Scale', 'Visual Analog Scala', 'Trait-Trait Anxiety Inventory', 'Postpartum Comfort Scale', 'Bristol Breastfeeding Assessment Tool', 'Uterine Involution Evaluation Form', 'Physiological Parameter Form' will be filled in again. . Participants in the control group will not receive massage and will receive routine nursing care. Pain, sleep, comfort, breastfeeding and heart rate, body temperature, anxiety, uterine involution, oxygen saturation, respiratory rate, blood pressure physiological parameters of women in the control group will be measured at the same time intervals.

Being tested
Back massage
Keywords
cesarean section, breastfeeding, sleep, anxiety, pain, comfort, uterine involution, back massage, physiological parameters
Medical subject headings
Breast Feeding, Anxiety Disorders, Pain

What participants receive

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

  • Back massageOther

    For the intervention group, massage will be given to the participant's back area by the researcher for 20 minutes, 12 hours after the cesarean birth. Preliminary data forms will be filled out by the participant before the massage. One hour after the massage, 'Visual Analog Scala' and 'Physiological Parameter Form' data will be filled in again. The final data forms will be filled out by the participant 24 hours after the cesarean birth, that is, 12 hours after the back massage.

Study groups in NCT06162156
Study groupRoleWhat they receive
back massage groupExperimentalVolunteer women who meet the inclusion criteria after cesarean delivery will be selected by a random method, and verbal and written consent will be obtained from those included in the intervention group. Pre-test data twelve hours after cesarean delivery: 'Personal Information Form', 'Trait-Trait Anxiety Inventory', 'Postpartum Comfort Scale (PCS)', 'Bristol Breastfeeding Assessment Tool (BBAT)', 'Uterine Involution Evaluation Form ( UIEF)' 'Physiological Parameter Form (PPF)' and 'Visual Analog Scale (VAS)' will be filled in by the participants themselves using face-to-face interview technique in approximately twenty minutes. The intervention group will receive a twenty-minute back massage after the initial data is received. One hour after the massage, 'VAS' and 'PPF data will be filled in again. Post-test data twenty-four hours after the massage; 'Richard Campbell Sleep Scale', 'VAS, 'Trait-Trait Anxiety Inventory', 'PCS', 'BBAT, 'UIEF, 'PPF will be filled in again..
Receives: Other: Back massage
control groupNo interventionVolunteer women who meet the inclusion criteria after cesarean delivery will be selected by random method, and verbal and written consent of those included in the control group will be obtained. Pre-test data twelve hours after cesarean delivery: 'Personal Information Form', 'Trait-Trait Anxiety Inventory', 'Postpartum Comfort Scale (PCS)', 'Bristol Breastfeeding Assessment Tool (BBAT)', 'Uterine Involution Evaluation Form ( UIEF)' 'Physiological Parameter Form (PPF)' and 'Visual Analog Scale (VAS)' will be filled in by the participants themselves using face-to-face interview technique in approximately twenty minutes. The control group will not be massaged anywhere in the study. Thirteen hours after cesarean delivery, 'VAS' and 'PPF data will be filled in again. Posttest data twenty-four hours after cesarean delivery; 'Richard Campbell Sleep Scale', 'VAS, 'Trait-Trait Anxiety Inventory', 'PCS', 'BBAT, 'UIEF, 'PPF will be filled in again.

What is being measured

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

  1. Visual Analog Scale

    It is used for pain assessment in musculoskeletal and other clinical evaluations. VAS is used to convert some values that cannot be measured numerically into numerical values. It is a frequently used measurement tool because it is easy to apply and safe. At the left end of the 10 cm long horizontal line are the words 'I have no pain' and at the right end the words 'I have pain'. The individual is told to mark the point on this horizontal line that best expresses the intensity of pain in his body. The distance of the point marked by the individual to the left end is measured and the pain score is determined. As the VAS value approaches 10, the intensity of the pain increases, and as it approaches 0, the intensity decreases. The lowest score from the scale is 0 and the highest score is 10.

    Measured: twenty four hours

Secondary outcomes (6)
  1. Richard-Campbell Sleep Scale

    The Richard-Campbell Sleep Scale was developed to evaluate sleep quality, and its Turkish validity and reliability were tested. The scale consists of 6 items that evaluate the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. The items in the scale are evaluated by scoring between 0-100. Scale scoring is done by dividing the total score from the first five items of the scale by 5. A score between '0-25' from the scale indicates 'very poor sleep', and a score between '76-100' indicates 'very good sleep'. Scale score is directly proportional to sleep quality. Accordingly, as the score increases, sleep quality also increases. Cronbach's alpha coefficient was found to be 0.82 in the original form of the scale and 0.91 in the Turkish form.

    Measured: twenty four hours

  2. Postpartum Comfort Scale

    Postpartum Comfort Scale is a scale developed in the form of a 5-point Likert to measure comfort level. Scoring and expressions ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were made for all scale items. The expression "I completely agree" expresses the highest comfort (5 points) in positive sentences, and the lowest comfort (1 point) in negative sentences. In this case, the highest score to be obtained from the scale is 170 and the lowest score is 34. The increase in the average score obtained from the scale indicates that the comfort level also increases. Cronbach's Alpha reliability coefficient of the scale is total Postpartum Comfort Scale was found to be 0.78 for.

    Measured: twenty four hours

  3. Bristol Breastfeeding Assessment Tool

    Bristol Breastfeeding Assessment Scale (BBAT) is used to evaluate the adequacy of breastfeeding in the postpartum period. The scale is observed while the mother is breastfeeding, and the application time is on average 5-10 minutes. The measurement tool is a Likert-type scale consisting of four items: 'positioning', 'holding', 'sucking' and 'swallowing'. In the scoring of the scale, each item is worth 0-2 points. The calculation method is to add up all the scores from the scale items. The lowest score from the scale is 0, the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective, and a high score indicates that breastfeeding is effective. There is no need to observe breastfeeding from start to finish to make an evaluation; observation can be made at any time during breastfeeding.

    Measured: twenty four hours

  4. State Anxiety Inventory (STAI Form)

    The State Anxiety Inventory is a Likert-type four-degree scale ranging from "Not at all" to "Completely". There are two types of statements in the State-Trait Anxiety Inventory. Inverted expressions, those with a weight of 1 turn into 4, and those with a weight of 4 turn into 1. Answers with a value of 4 on 33 direct statements indicate high anxiety. In reversed expressions, answers with a value of 1 indicate high anxiety, and answers with a value of 4 indicate low anxiety. After finding the separate total weights of direct and reverse expressions, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions. This value is 50 for the State Anxiety Inventory and 35 for the Trait Anxiety Inventory. The last value obtained is the individual's anxiety score. The scores obtained from both scales theoretically range between 20 and 80. A large score indicates a high level of anxiety, a small score indicates a low level of anxiety.

    Measured: twenty four hours

  5. Uterine Involution Evaluation Form

    Immediately after uterine involution and delivery of the placenta, the apex of the fundus is located in the midline, between the symphysis and the umbilicus. 6-12 hours after birth, the fundus is at the umbilicus level and the height of the fundus decreases approximately 1 cm every day. Uterus Involution Evaluation Form is a form prepared by the researcher in line with the literature, in which the measurement of the length of the uterus is recorded and the uterine involution process of postpartum women is evaluated. To evaluate the involution of the uterus, the distance between the fundus of the uterus and the symphysis pubis will be measured with a tape measure. Uterine length will be measured when the women's bladder is empty and the same tape measure will be used in all measurements.

    Measured: twenty four hours

  6. Physiological Parameter Form

    Physiological parameters are important indicators in the management of the postpartum period and in determining the treatment protocol. Heart rate, body temperature, oxygen saturation, respiratory rate and blood pressure, which are stated as basic life parameters, are parameters that indicate the health status of the person. Although physiological parameter values vary individually, according to the standards determined by the World Health Organization, blood pressure is 8/120 mm/hg, body temperature 36.1°C-37.2°C, pulse rate of 60-100 beats per minute, respiratory rate of 12-20 per minute, and oxygen saturation of 95-100% are considered normal. For this purpose, the Physiological Parameter Form includes heart rate, body temperature, oxygen saturation, respiratory rate and blood pressure.

    Measured: twenty four hours

Timeline

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

  1. First posted8 Dec 2023
  2. Study start1 Dec 2023
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 May 2024 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two groups with back massage experimental group and control group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162156
Sponsor's protocol ID
OÜ-HEM-EG-02
Status last verified
Dec 2023
First submitted
1 Dec 2023
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) can be shared with other researchers via e-mail sent to me after the study is completed, when a meta-analysis study will be conducted.

Questions about this trial

What is this clinical trial studying?

A study testing Back massage in people with Cesarean Section, run by Ordu University 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 11 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 8 Dec 2023. 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 Esra GÜLER EG PhD student (0545 628 25 12, esraguleravza0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: twenty four hours). 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 8 Dec 2023.

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