Clinical trial NCT06162156: Effects of Back Massage After Cesarean Section
Official title: The Effect of Back Massage After Cesarean on Pain, Anxiety, Sleep, Breastfeeding, Comfort, Uterine Involution and Physiological Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section
Keywords: cesarean section
breastfeeding
sleep
anxiety
pain
comfort
uterine involution
back massage
physiological parameters
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with back massage experimental group and control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: twenty four hours
Secondary outcomes:
measure: Richard-Campbell Sleep Scale
timeFrame: twenty four hours
measure: Postpartum Comfort Scale
timeFrame: twenty four hours
measure: Bristol Breastfeeding Assessment Tool
timeFrame: twenty four hours
measure: State Anxiety Inventory (STAI Form)
timeFrame: twenty four hours
measure: Uterine Involution Evaluation Form
timeFrame: twenty four hours
measure: Physiological Parameter Form
timeFrame: twenty four hours
Other outcomes:
Locations:
city: Fatsa
country: Turkey
facility: Fatsa State Hospital
state: Ordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Esra GÜLER EG PhD student
role: PRINCIPAL_INVESTIGATOR
References: