Effect of Progressive Relaxation Exercises and TENS on Women Delivering Via Cesarean

Acute Pain Clinical Trial

Official title:

The Effect of Progressive Relaxation Exercises and Transcutaneous Electrical Nerve Stimulation Administered to Women Delivering Via Cesarean Section on Acute Pain, Breastfeeding Behaviors, and Comfort Levels: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511571
• Other study ID #: KA-17142
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2022
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to determine the effect of progressive relaxation exercises and transcutaneous electrical nerve stimulation administered to women delivering via cesarean section on acute pain, breastfeeding behavior, and comfort levels. Single-Blind, Randomized Controlled Study. This study was carried out in the obstetrics and gynecology clinic of a university hospital affiliated with the Ministry of Health in Turkey between August 20, 2018 and April 15, 2019. A total of 120 participants were randomly assigned to one of four groups, which included a transcutaneous electrical neural stimulation (TENS) group, a progressive relaxation exercises (PRE) group, a combined intervention (TENS+PRE) group, and a control group. Data were collected with a data collection form, the visual analogue scale (VAS), the LATCH breastfeeding diagnostic tool (LATCH), and the postpartum comfort scale (PCS). In the analysis of the data, numbers, percentages, and chi-square tests were used. Also, median values, Wilcoxon Signed-rank test, and Kruskal-Wallis H test were employed for continuous variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women who were aged between 18 and 45,
• who were in the postoperative 8th hour,
• who had a transverse cesarean section,
• who, as well as their babies, did not develop any complications during pregnancy, delivery, and the postpartum period.

Exclusion Criteria:

• women who did not have an open wound on their body and/or allergic disease on their skin,
• who had cardiac arrhythmia or a pacemaker,
• who had a risk of epilepsy,
• who had epilepsy, eclampsia, kidney or liver disease,
• who had previously applied TENS and PRE methods,
• who were morbidly obese (with a BMI value of over 40),
• who used chronic opioids, antidepressants, and psychoactive drugs.

Related Conditions & MeSH terms

• Acute Pain
• Cesarean Section

Intervention

Device:
• Transcutaneous electrical neural stimulation (TENS)
The TENS group: TENS application was implemented by the researchers in the patient room. The conventional TENS application took 30 minutes per session. The application continued until frequency reached 100 Hz, the pulse width reached 100 µs, and the current impedance reached a point where the women felt needling or tingling according to their tolerance. Before the application, the women were asked to lie in a supine position, and the area/skin where TENS would be applied was cleaned and dried. Two electrodes of TENS were placed 2 cm above the cesarean incision, and the other two electrodes 2 cm below the incision. The women were allowed to rest during the application, and they were accompanied by the researcher. A total of five TENS sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held.

Other:
• Progressive relaxation exercises (PRE)
The PRE group: The PRE application was implemented in the patient room. A quiet and calm environment was prepared in the room for the intervention. The PRE application was implemented by the women under the researchers' instructions. Each session lasted 30 minutes. A total of five sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held. The PRE application includes exercises based on stretching and then the relaxation of different muscle groups, accompanied by deep breathing. The exercises were carried out in the following way: First doing a deep breathing exercise and then stretching all the muscles from feet to face accompanied by breathing in, keeping the breath, and finally relaxing the muscles by breathing out at the same time.
• Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
The TENS+PRE group: The PRE and TENS applications were carried out together in this group. The administration of the interventions was the same as in groups where only TENS and only PRE applications were carried out. In this group, first, a 30-minute PRE application was implemented, which was followed by a 30-minute-TENS application.

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Derya Öztürk Özen	Hacettepe University, Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in acute pain	The Visual Analog Scale (VAS) was used in the evaluation of acute pain.	VAS was applied in the first eighth hour during the postoperative 48 hours, before and after each application in the intervention groups, and in the control group at the times corresponding to the applications in the intervention groups.
Secondary	Change in breastfeeding behavior	The LATCH Breastfeeding Diagnostic Tool (LATCH) was used in the evaluation of breastfeeding behavior.	LATCH was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.
Secondary	Change in comfort level	The Postpartum Comfort Scale was used in the evaluation of comfort level.	Postpartum Comfort Scale was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.