The Effect of TENS Applied in the Early Postpartum Period on Incision Healing, Pain and Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Postoperative Recovery Index (PoRI)
研究概览
简要总结
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).
详细描述
Introduction The postpartum period is a period with biopsychosocial effects in the life of the mother and her family. The mode of delivery may affect the adaptation of the mother to the postpartum period. Most women can have a vaginal birth with professional support. However, vaginal delivery can be risky in cases of fetal distress, large fetus, head and pelvis incompatibility, fetal posture disorders, and maternal illness that may prevent vaginal delivery. In these cases, cesarean section is an important decision for the health of both mother and baby. However, cerzerian surgery also brings some risks. Pain in the short term, difficulty in the recovery of the mother, delayed mobilization, infection, exposure to a surgical operation and a decrease in maternal comfort due to these may cause many problems such as breastfeeding problems, decreased mother-baby bonding.
The presence of persistent pain after cesarean section is the result of post-operative inflammatory reactions and adversely affects the mother. In a study, it was reported that 75% of women experienced moderate or severe pain after cesarean section, and this pain was high in the first 24 hours. The duration of pain may be prolonged depending on the individual's perception of pain and response to pain. It delays early mobilization by delaying pain relief and reduces maternal comfort. Effective treatment of pain is very important economically and because of its unpleasant physiological and psychological consequences for the patient. Recently, many methods have been developed with pharmacological and non-pharmacological approaches to pain in women with severe pain after cesarean section, and it has been reported that they accelerate pain, maternal satisfaction, recovery time and delay the use of analgesics. These include TENS, acupuncture, breathing exercises, and psychotherapy.
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacological, low-frequency electrotherapy technique. The mechanism of action of TENS is still unknown. It was first used in obstetrics in 1970. It has been reported in the literature that TENS is used in chronic pain such as post-operative pain, vaginal delivery pain, dysmenorrhea, angina pectoris, orofacial pain, dental procedures, physical trauma-broken ribs and minor medical procedures, low back pain. Despite the widespread use of TENS in vaginal labor pain, it has been included in systematic reviews for which evidence of benefit is insufficient. In addition, it has been reported that TENS is effective in wound healing and faster wound area reduction in some dermatological studies and plastic surgery. It has been reported that TENS supports the long-term retention of flaps and grafts after plastic surgery, thereby accelerating postoperative recovery and reducing necrosis. The effectiveness of TENS in wound healing has been associated with an increase in blood flow (Visconti et al., 2020). However, there is no study in the literature that determines the effect of TENS on incision healing, pain and comfort after cesarean section.
Considering the cesarean section rates in the world and in Turkey, the importance of these risks emerges. While the Dominican Republic ranks first with 56.4% in the WHO's cesarean section rates, Turkey ranks fourth in this ranking. The rate of cesarean section in Turkey was determined to be 52% in 2018, according to the report of the Turkey Demographic and Health Survey (TNSA).
Considering the problems mentioned above, it is important to search for non-pharmacological interventions that will minimize health risks along with full holistic care for mothers in the post-cesarean period. Therefore, in this study, it was aimed to determine the effect of TENS applied in the early postpartum period at the end of the cesarean section on incision healing, pain and comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older,
- •having a single healthy newborn.
排除标准
- •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.
结局指标
主要结局
Postoperative Recovery Index (PoRI)
时间窗: Change from PoRI at 16 hours after cesarean section
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.
次要结局
- REEDA Scale(Change from REEDA at 16 hours after cesarean section)
研究者
Esra SABANCI BARANSEL
Assit. Prof
Inonu University
