The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and the Number of Steps

Sponsor

Mersin University (Other)

Overall Status

Completed

CT.gov ID

NCT05311449

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

74.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps.

Condition or Disease	Intervention/Treatment	Phase
Pain Mobilization	Other: Acupressure Other: Plasebo acupressure	N/A

Detailed Description

Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, parallel, two-arm, randomized controlled clinical trial, double blindProspective, parallel, two-arm, randomized controlled clinical trial, double blind

Masking:

None (Open Label)

Masking Description:

In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to women. However, the researcher (A.A.) who will apply acupressure and placebo acupressure be blinded without knowing whether these points are acupressure or placebo points. Participants will not know that they are in the acupressure or placebo group. Thus, the research will be carried out as a double-blind randomized controlled trial. When the research is completed, the data of the control and study groups (A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.

Primary Purpose:

Supportive Care

Official Title:

The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and the Number of Steps in the First Mobilization: A Double-blind Randomized Controlled Trial.

Actual Study Start Date :

Jun 26, 2022

Actual Primary Completion Date :

Jun 26, 2022

Actual Study Completion Date :

Jul 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupressure Group (experimental) The experimental group will be given acupressure.	Other: Acupressure The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes. Other Names: Acupress
Placebo Comparator: Placebo Acupressure Group (control) The placebo group will be given placebo acupressure.	Other: Plasebo acupressure In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less. Other Names: Placebo Acupress

Arm

Intervention/Treatment

Experimental: Acupressure Group (experimental)

The experimental group will be given acupressure.

Other: Acupressure

The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.

Other Names:

Acupress

Placebo Comparator: Placebo Acupressure Group (control)

The placebo group will be given placebo acupressure.

Other: Plasebo acupressure

In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.

Other Names:

Placebo Acupress

Outcome Measures

Primary Outcome Measures

Pain evaluated using the visual analog scale [Change from before implementation and after 1 minute, 2nd and 4th hour after implementation]
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.

Secondary Outcome Measures

The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China) [Change 4th hour after acupressure]
The number of steps in the first mobilization will be evaluated with a pedometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Being conscious,
The mother tongue is Turkish,
To be oriented and cooperative,
be between 18-45 years old,
To voluntarily agree to participate in the study (signing the Informed Consent Form),
Repeated cesarean section,
Cesarean section under spinal anesthesia,
Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
No health problems of the fetus,
To have given birth by cesarean section between 37-40 weeks,
To be in the second hour of the postpartum period,
Not receiving post-op patient-controlled analgesia,
Not to have smoked or used alcohol during pregnancy,
No complications in the mother and/or newborn after cesarean section,
No sensitivity in the area where acupressure will be applied,
Absence of any systemic or psychiatric diagnosis,
Absence of active COVID-19 infection.

Exclusion Criteria:

Lack of consciousness,
The mother tongue is not Turkish,
Not oriented and cooperative,
Not to be between the ages of 18-45,
Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
Normal birth or cesarean delivery under general anesthesia,
Cesarean delivery due to the risk of deterioration of maternal or fetal health,
Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
Not giving birth outside 37-40 weeks and by cesarean section,
Not in the second hour of the postpartum period,
Receiving post-op patient-controlled analgesia,
To have used cigarettes and alcohol during pregnancy,
Sensitivity in the area where acupressure will be applied,
Presence of any systemic or psychiatric diagnosis,
Active COVID-19 infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mersin University	Mersin	Yenişehir	Turkey	33343

Sponsors and Collaborators

Mersin University

Investigators

Study Director: Duygu VEFİKULUÇAY YILMAZ, Doctorate, Mersin University
Principal Investigator: Aslıhan AKSU, master, Mersin University
Principal Investigator: Filiz DEĞİRMENCİ, master, Mersin University
Principal Investigator: Gülay ALTUN UĞRAŞ, doctorate, Mersin University
Principal Investigator: Mürşide ÇEVİKOĞLU KILLI, doctorate, Mersin City Hospital