Effects of Back Massage After Cesarean Section

NCT06162156 | Unknown

• 1 other identifier: OÜ-HEM-EG-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cesarean Section

Keywords

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

Outcome Measures

Primary Outcomes (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.

  twenty four hours

Secondary Outcomes (6)

• Richard-Campbell Sleep Scale

  twenty four hours

• Postpartum Comfort Scale

  twenty four hours

• Bristol Breastfeeding Assessment Tool

  twenty four hours

• State Anxiety Inventory (STAI Form)

  twenty four hours

• Uterine Involution Evaluation Form

  twenty four hours

Study Arms (2)

back massage group

EXPERIMENTAL

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..

Other: Back massage

control group

NO INTERVENTION

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.

Interventions

Back massage 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.

back massage group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: The gender required to sample women who gave birth by cesarean section must be female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Fatsa State Hospital

Fatsa, Ordu, 52400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra GÜLER EG PhD student

  Ordu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: two groups with back massage experimental group and control group

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)