MedDataX Logo

Effects of Back Massage After Cesarean Section

NCT ID: NCT06162156

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cesarean section breastfeeding sleep anxiety pain comfort uterine involution back massage physiological parameters

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups with back massage experimental group and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Which group will be the intervention group and which group will be the control group will be determined by lottery. After the participant agrees to participate in the research, the person will draw envelopes from sealed envelopes by lottery and thus it will be determined which group he/she is in. Since the researcher and the mothers, who are massage practitioners, knew which group they were included in, the data collection phase of the study could not be blinded. Since the statistical analysis of the study will be performed by an independent statistician other than the researcher, the statistical analysis phase is blind. Therefore, the study is single blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

back massage group

Volunteer 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..

Group Type EXPERIMENTAL

Back massage

Intervention Type OTHER

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.

control group

Volunteer 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Back massage

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ordu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esra Guler

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esra GÜLER EG PhD student

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fatsa State Hospital

Fatsa, Ordu, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Esra GÜLER EG PhD student

Role: CONTACT

Phone: 0545 628 25 12

Email: [email protected]

Nülüfer ERBİL NE Prof. Dr.

Role: CONTACT

Phone: 0535 830 63 57

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Esra EG Güler, 4

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OÜ-HEM-EG-02

Identifier Type: -

Identifier Source: org_study_id