The Effect of TENS Applied in the Early Postpartum Period on Incision Healing, Pain and Comfort

NCT05991921 | Completed

• 1 other identifier: 2023/ 02- 13
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: In this study, it was aimed to determine the effect of TENS applied in the early postpartum period after cesarean section on incision healing, pain and comfort. Methods: This study was designed as randomized, single-blind, placebo-controlled. All participants signed an informed consent statement before starting the study. The study sample of 138 (TENS group n=46, placebo group n=46, control group n=46). TENS application, postpartum 10-12. at hours and 14-16. It was applied twice for 30 minutes each. Researcher 1 programmed the TENS unit and was the only researcher who knew whether TENS was active or in placebo mode. The pretest data were applied to the participants who met the inclusion criteria and volunteered to participate in the study, in the patient rooms 10 hours after the cesarean section. Post-test data were obtained by the same investigator 16 hours after cesarean section. Data were obtained with Personal Information Form, Postoperative Recovery Index (PoRI), REEDA Scale, Visual Analogue Scale (VAS), and Postpartum Comfort Scale (PPCQ).

Conditions

Postoperative Recovery; Wound Healing; Postpartum Comfort; Postpartum Pain

Keywords

Transcutaneous Electrical Nerve Stimulation; wound healing; cesarean section; pain; comfort; Recovery; postpartum period

Outcome Measures

Primary Outcomes (1)

• Postoperative Recovery Index (PoRI)

  The PoRI index consists of 5 sub-dimensions and 25 items. Sub dimensions; psychological symptoms, physical activities, appetite symptoms, intestinal symptoms, and general symptoms. The scores of the items in the sub-dimensions are summed, their averages are calculated, and the sub-dimension scores are determined. For the PoRI total score, all 25 items are summed and averaged. High scores obtained from the index indicate that there are more problems in postoperative recovery, while low scores indicate that recovery is easier after surgery.

  Change from PoRI at 16 hours after cesarean section

Secondary Outcomes (1)

• REEDA Scale

  Change from REEDA at 16 hours after cesarean section

Other Outcomes (2)

• Visual Analogue Scale (VAS)

  Change from REEDA at 16 hours after cesarean section

• Postpartum Comfort Scale (PPCQ)

  Change from REEDA at 16 hours after cesarean section

Study Arms (3)

Transcutaneous Electrical Nerve Stimulation"

EXPERIMENTAL

TENS application, postpartum 10-12. at hours and 14-16. It was applied twice for 30 minutes each.Two pairs of TENS electrodes were placed on the upper and lower border of the cesarean section incision line. A total of 4 electrodes were used in a sterile package for each participant. TENS stimulation was applied at a frequency of 100 Hz and was increased starting from 0 mA. The participant's stimulation was fixed at the mA level, where he felt optimal but did not feel discomfort. All participants in the TENS, received all other routine obstetric care provided by hospital healthcare professionals.

Other: Transcutaneous Electrical Nerve Stimulation (TENS)

Plasebo

SHAM COMPARATOR

Participants in the placebo group 10-12 postpartum. at hours and 14-16. Two pairs of TENS electrodes were placed at the same time as the intervention group. TENS electrodes were attached to the participants in this group for 30 minutes, the device was operated but no electric current was applied.

Other: Plasebo-Fake TENS

Control

NO INTERVENTION

Participants in the control group were not dependent on TENS. All participants in the control group received all other routine obstetric care provided by hospital healthcare professionals.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) OTHER

TENS application, postpartum 10-12. at hours and 14-16. It was applied twice for 30 minutes each. Researcher 1 programmed the TENS unit and was the only researcher who knew whether TENS was active or in placebo mode. Two pairs of TENS electrodes were placed on the upper and lower border of the cesarean section incision line. A total of 4 electrodes were used in a sterile package for each participant. TENS stimulation was applied at a frequency of 100 Hz and was increased starting from 0 mA. The participant's stimulation was fixed at the mA level, where he felt optimal but did not feel discomfort. The pretest data were applied to the participants who met the inclusion criteria and volunteered to participate in the study, by the researcher 2 in the patient rooms 10 hours after the cesarean section. Post-test data were obtained by the same investigator 16 hours after cesarean section.

Transcutaneous Electrical Nerve Stimulation"

Plasebo-Fake TENS OTHER

Participants in the placebo group 10-12 postpartum. at hours and 14-16. Two pairs of TENS electrodes were placed at the same time as the intervention group. TENS electrodes were attached to the participants in this group for 30 minutes, the device was operated but no electric current was applied.

Plasebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: being ≥18 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• having a single healthy newborn.

You may not qualify if:

• cesarean section under general anesthesia,
• any postpartum complication (such as bleeding, hypertension),
• skin damage at TENS application sites,
• morbidly obese,
• cardiac women using a pacemaker or automated implanted cardiac defibrillator,
• previously using TENS,
• receiving repeated doses of analgesics other than those routinely administered after surgery.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Fırat University

Elâzığ, Province, 23119, Turkey (Türkiye)

Location

Related Publications (1)

• Sabanci Baransel E, Barut S, Ucar T. The Effects of Transcutaneous Electrical Nerve Stimulation Applied in the Early Postpartum Period After Cesarean Birth on Healing, Pain, and Comfort. J Midwifery Womens Health. 2024 Sep-Oct;69(5):681-688. doi: 10.1111/jmwh.13625. Epub 2024 Mar 12.

  PMID: 38470299 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Based on simple randomization, women were assigned to one of three groups: TENS (n=46), placebo (n=46), or control (n=46). For randomization, researcher 1 used the random number generation method available on the random.org site. These processes are hidden from the rest of the study. While TENS application in the research was carried out by researcher 1; It was conducted by researcher 2, who evaluated the participants for inclusion and exclusion criteria and collected the data, who did not know the distribution of the participants. Because sham device TENS was not applied to the control group, the participants were able to realize that they were assigned to the control group. Therefore, this study was considered a single-blind study. To provide blinding in the placebo group, the participants were hooked up to the TENS unit in exactly the same way as the participants in the TENS group. The active indicator of the unit emitted light and sound, but did not transmit electrical stimulation
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assit. Prof

Model Details: This study was designed as randomized, single-blind, placebo-controlled.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: January 26, 2023
• Primary Completion: June 26, 2023
• Study Completion: August 5, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)